78. Hypopituitarism
[
244 clinical trials,
222 drugs（DrugBank:
44 drugs),
44 target genes / 78 target pathways ]
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04121780 | October 8, 2019 | 28 October 2019 | Growth Hormone Replacement Therapy for Retried Professional Football Players | Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency | TBI (Traumatic Brain Injury);Concussion, Brain;Sport Injury;Anterior Pituitary Hyposecretion Syndrome;Hypopituitarism;Growth Hormone Deficiency | Biological: Growth Hormone;Other: Placebo | Center for Neurological Studies | Novo Nordisk A/S | Recruiting | 18 Years | 76 Years | Male | 42 | Phase 2 | United States |
| 2 | NCT04020913 | July 22, 2019 | 22 October 2019 | Skeletal Muscle Effects of GH in Boys | Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency | Growth Hormone Deficiency;Idiopathic Short Stature | Drug: Somatropin injection | Nemours Children's Clinic | Novo Nordisk A/S | Recruiting | 6 Years | 11 Years | Male | 45 | N/A | United States |
| 3 | NCT03972345 | June 21, 2019 | 15 July 2019 | Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA) | Growth Hormone Deficiency in Children;Born Small for Gestational Age | Drug: Norditropin® FlexPro® | Novo Nordisk A/S | Recruiting | N/A | 15 Years | All | 750 | Phase 1 | Germany | |
| 4 | NCT03811535 | May 20, 2019 | 28 October 2019 | A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day | A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency | Growth Hormone Deficiency in Children | Drug: Somapacitan;Drug: Norditropin® | Novo Nordisk A/S | Recruiting | 2 Years | 11 Years | All | 192 | Phase 3 | United States;Algeria;Austria;Denmark;France;Germany;India;Israel;Italy;Japan;Korea, Republic of;Russian Federation;Slovenia;Switzerland;Ukraine;United Kingdom | |
| 5 | NCT03500913 | May 2019 | 4 March 2019 | Adipose Tissue and Serum Inflammation in GH Deficiency | Adipose Tissue and Serum Inflammation in Growth Hormone (GH) Deficiency | Growth Hormone Deficiency | Drug: Growth Hormone | Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 65 Years | All | 60 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03878992 | April 30, 2019 | 7 October 2019 | Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle | Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle | Growth Hormone Deficiency;Growth Hormone Treatment | Drug: Genotropin miniquick 0.5 mg, injection | University of Aarhus | Aarhus University Hospital | Recruiting | 18 Years | 100 Years | All | 12 | N/A | Denmark |
| 7 | NCT03905850 | March 29, 2019 | 26 August 2019 | A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects | A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL | Healthy Volunteers;Growth Hormone Deficiency | Drug: somapacitan | Novo Nordisk A/S | Not recruiting | 18 Years | 45 Years | All | 33 | Phase 1 | Germany | |
| 8 | NCT03775993 | March 1, 2019 | 25 February 2019 | Treatment of GHD Associated With CHF | Treatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study | Heart Failure;Growth Hormone Deficiency | Drug: Human growth hormone;Other: Placebo | Federico II University | Not recruiting | 18 Years | 85 Years | All | 64 | Phase 3 | ||
| 9 | NCT03831880 | February 7, 2019 | 7 October 2019 | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD | A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY | Growth Hormone Deficiency | Drug: Genotropin;Drug: somatrogon | Pfizer | Recruiting | 3 Years | 17 Years | All | 90 | Phase 3 | United States;Czechia;United Kingdom | |
| 10 | EUCTR2018-001988-23-HU | 07/11/2018 | 12 November 2018 | A clinical study with macimorelin acetate comparing three doses in their safety and tolerability in children with suspected growth hormone deficiency (GHD) | Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD) | Diagnosis of Growth Hormone Deficiency MedDRA version: 20.0 Level: LLT Classification code 10073227 Term: Growth hormone stimulation test System Organ Class: 100000004848 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Macrilen Product Name: macimorelin Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: macimorelin CAS Number: 381231-18-1 Current Sponsor code: AEZS-130 Other descriptive name: MACIMORELIN ACETATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 63.6- | Aeterna Zentaris GmbH | Authorised | Female: yes Male: yes | 24 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Russian Federation | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | ChiCTR1800017144 | 2018-07-25 | 16 July 2018 | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | A diverse response study of Pegylated Somatropin to treat growth hormone deficiency children | Growth hormone deficiency | Two groups:low dose versus high dose of Pegylated Somatropin; | The Children's Hospital, Zhejiang University School of Medicine | Recruiting | 3 | 14 | Both | Two groups:900; | Post-market | China‘ | |
| 12 | NCT03274973 | May 14, 2018 | 18 December 2018 | Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome | A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome | Growth Disorders | Drug: Zomacton | Ferring Pharmaceuticals | Not recruiting | N/A | 18 Years | All | 4 | Phase 2/Phase 3 | Germany | |
| 13 | NCT03226821 | February 7, 2018 | 11 June 2018 | Body Composition and Adipose Tissue in HIV | Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy | HIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body Composition | Drug: Tesamorelin | Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 18 Years | 68 Years | All | 24 | Phase 4 | United States |
| 14 | JPRN-JapicCTI-183963 | 25/12/2017 | 16 July 2019 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, 12-MONTH, EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN JAPANESE PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY | Treatment of children with growth failure due to growth hormone deficiency (GHD) | Intervention name : MOD-4023 (long-acting modified r-hGH) INN of the intervention : somatrogon Dosage And administration of the intervention : MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. Control intervention name : Genotropin INN of the control intervention : somatropin Dosage And administration of the control intervention : daily Genotropin (0.025 mg/kg/day). | OPKO Health Inc.(ICCC: EPS International Holdings Co., Ltd) | Not Recruiting | 3 | 11 | BOTH | 44 | Phase 3 | Japan | |
| 15 | NCT03344458 | December 19, 2017 | 21 January 2019 | A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial | enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma A/S | Recruiting | 1 Year | 18 Years | All | 300 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03874013 | December 7, 2017 | 3 June 2019 | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency | A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin® Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Genotropin;Drug: MOD-4023 | OPKO Health, Inc. | Not recruiting | 3 Years | 11 Years | All | 44 | Phase 3 | Japan | |
| 17 | NCT03305016 | November 13, 2017 | 3 June 2019 | A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency | fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD | Growth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary Diseases | Drug: TransCon hGH | Ascendis Pharma A/S | Not recruiting | 6 Months | 17 Years | All | 146 | Phase 3 | United States;New Zealand;Canada;Australia | |
| 18 | NCT03053687 | November 1, 2017 | 11 June 2018 | Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy | Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled Trial | IGHD - Isolated Growth Hormone Deficiency;Growth Retardation | Dietary Supplement: Nutritional supplementation standardized formula;Dietary Supplement: Placebo | Rabin Medical Center | Recruiting | 3 Years | 14 Years | All | 64 | N/A | Israel | |
| 19 | NCT03212131 | August 16, 2017 | 3 June 2019 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 34 | Phase 1 | Slovakia | |
| 20 | NCT03225755 | August 1, 2017 | 4 March 2019 | Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy | Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy | Growth Hormone Deficiency | Drug: Growth hormone | Columbia University | Novo Nordisk A/S | Recruiting | 18 Years | 65 Years | All | 12 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03186495 | June 20, 2017 | 18 June 2018 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children | Drug: Somapacitan | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | All | 44 | Phase 1 | Germany | |
| 22 | EUCTR2016-003874-42-GB | 05/04/2017 | 3 July 2017 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 19.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatrogon CAS Number: 1663481-09-1 Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatrogon CAS Number: 1663481-09-1 Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN FOR INJECTION Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN FOR INJECTION Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- | OPKO Biologics Ltd. | Authorised | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | |||
| 23 | NCT03104010 | April 2017 | 16 December 2017 | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD | A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Somatropin Injection | GeneScience Pharmaceuticals Co., Ltd. | Peking Union Medical College Hospital;Peking University First Hospital;Hebei General Hospital;The Second Hospital of Hebei Medical University;Qilu Hospital of Shandong University;Second Affiliated Hospital, School of Medicine, Zhejiang University;The First Affiliated Hospital of Soochow University;First Affiliated Hospital of Chongqing Medical University;Chongqing Three Gorges Central Hospital;West China Hospital | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | China |
| 24 | NCT03145831 | March 31, 2017 | 11 June 2018 | A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency | An Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somavaratan | Versartis Inc. | Not recruiting | 3 Years | N/A | All | 21 | Phase 3 | United States;Japan | |
| 25 | NCT03075644 | March 3, 2017 | 28 October 2019 | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin | Novo Nordisk A/S | Not recruiting | 18 Years | 79 Years | All | 62 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03290235 | March 1, 2017 | 8 January 2018 | Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children | Growth Retardation | Drug: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Recruiting | 42 Months | 15 Years | All | 1500 | Phase 4 | China | |
| 27 | JPRN-UMIN000027260 | 2017/02/06 | 2 April 2019 | Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading | Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons. | Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutes | Osaka City University Graduate School of Medicine | 2years-old | 15years-old | Male and Female | 15 | Not selected | Japan | |||
| 28 | NCT02781727 | December 13, 2016 | 29 April 2019 | A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases | Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin | Ascendis Pharma A/S | Not recruiting | 3 Years | 12 Years | All | 161 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine | |
| 29 | NCT02968004 | December 2016 | 15 July 2019 | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | Opko Biologics | Not recruiting | 3 Years | 11 Years | All | 224 | Phase 3 | United States;Argentina;Australia;Belarus;Bulgaria;Canada;Colombia;Georgia;Greece;India;Israel;Korea, Republic of;Mexico;New Zealand;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Germany;Italy;Turkey | |
| 30 | NCT03309891 | December 2016 | 16 December 2017 | Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency | A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | Not recruiting | 3 Years | 11 Years | All | 48 | Phase 2 | Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT02871986 | September 2016 | 29 August 2016 | Pubertal Induction in Individuals With Hypogonadism | Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism. | Primary Amenorrhoea;Hypothalamic Amenorrhoea;Hypogonadotrophic Hypogonadism;Hypopituitarism;Turner's Syndrome;Primary Ovarian Insufficiency | Drug: Routine transdermal oestrogen patch | University College, London | Not recruiting | 10 Years | 30 Years | Both | 24 | N/A | United Kingdom | |
| 32 | NCT03015909 | August 11, 2016 | 14 January 2019 | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. | A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device | Short Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner Syndrome | Drug: Somatropin | LG Life Sciences | Not recruiting | 4 Years | 15 Years | All | 116 | Phase 4 | Korea, Republic of | |
| 33 | NCT03203356 | May 30, 2016 | 16 December 2017 | Adrenal Function in GHD Children | Evaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH Deficiency | Growth Hormone Treatment;Adrenal; Functional Disturbance | Drug: growth hormone | University of Palermo | Not recruiting | 5 Years | 12 Years | All | 30 | N/A | Italy | |
| 34 | NCT02782208 | May 2016 | 30 May 2016 | Lipolytic Effects of GH in Hypopituitary Patients in Vivo | Lipolytic Effects of GH in Hypopituitary Patients in Vivo: Molecular Mechanisms and Temporal Patterns. | Hypopituitarism;Insulin Resistance;Endocrine System Diseases;Glucose Metabolism Disorders;Metabolic Diseases;Pituitary Diseases;Brain Diseases | Drug: Acipimox;Drug: Placebo;Drug: GH substitution;Other: GH pause | University of Aarhus | Recruiting | 18 Years | 70 Years | Male | 8 | N/A | Denmark | |
| 35 | NCT02616562 | March 23, 2016 | 20 May 2019 | Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: Norditropin® FlexPro® pen | Novo Nordisk A/S | Not recruiting | 30 Months | 10 Years | All | 59 | Phase 2 | United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT02719990 | February 9, 2016 | 11 June 2018 | Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD | An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD) | Adult Growth Hormone Deficiency (AGHD) | Drug: somavaratan | Versartis Inc. | Premier Research Group plc | Not recruiting | 18 Years | 75 Years | All | 34 | Phase 2 | Australia;United States |
| 37 | EUCTR2016-000446-56-Outside-EU/EEA | 11 April 2016 | Clinical study to compare recombinant human growth hormone Cristalia (r-hGH Cristalia) versus Genotropin® in prepubertal children with growth deficiency due to deficiency of growth hormone. | Clinical study to compare recombinant human growth hormone Cristalia (r-hGH Cristalia) versus Genotropin® in prepubertal children with growth deficiency due to deficiency of growth hormone. - CERES | Growth deficiency due to growth hormone deficiency MedDRA version: 18.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: NA Pharmaceutical Form: Lyophilisate and solvent for suspension for injection INN or Proposed INN: NA CAS Number: 12629015 Current Sponsor code: CRT076 Other descriptive name: SOMATROPIN Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 16- Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Lyophilisate and solvent for suspension for injection INN or Proposed INN: NA CAS Number: 12629015 Current Sponsor code: CRT076 Other descriptive name: SOMATROPIN Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 16- | Cristália Produtos Químicos Farmacêuticos Ltda. | Not Available | Female: yes Male: yes | 94 | Brazil | |||||
| 38 | EUCTR2016-003874-42-FR | 28 February 2019 | An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency - N/A | Growth hormone deficiency in pre-pubertal children MedDRA version: 20.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatrogon CAS Number: 1663481-09-1 Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatrogon CAS Number: 1663481-09-1 Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN FOR INJECTION Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN FOR INJECTION Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- | OPKO Biologics Ltd. | Not Available | Female: yes Male: yes | 220 | Phase 3 | Serbia;Belarus;United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;India;France;Australia;Netherlands;Turkey;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;New Zealand | ||||
| 39 | EUCTR2015-000531-32-AT | 10/12/2015 | 9 January 2017 | A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone | A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 19.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3.3- Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: Norditropin FlexPro 10 mg/1.5 ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- | Novo Nordisk A/S | Authorised | Female: yes Male: yes | 60 | Phase 2 | United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden | |||
| 40 | NCT02558829 | December 3, 2015 | 11 June 2018 | Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency | Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT) | Growth Hormone Deficiency With Pituitary Anomalies | Drug: Macimorelin;Drug: Insulin | AEterna Zentaris | Not recruiting | 18 Years | 65 Years | All | 157 | Phase 3 | United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2015-002072-24-DE | 22/10/2015 | 8 January 2018 | A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose. | An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD) Versartis International Trial in Adults with Long Acting Growth Hormone. The VITAL study - Versartis International Trial in Adults with Long Acting Growth Hormone (VITAL) | Growth Hormone Deficiency in adults MedDRA version: 18.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan Product Code: VRS-317 Pharmaceutical Form: Solution for injection INN or Proposed INN: Somavaratan CAS Number: 1448335-08-7 Other descriptive name: VRS-317 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Versartis Inc. | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Australia;Germany;United Kingdom | |||
| 42 | NCT02339090 | August 24, 2015 | 11 June 2018 | Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency. | Growth Disorders | Drug: somavaratan;Drug: Daily rhGH | Versartis Inc. | Not recruiting | 3 Years | 11 Years | All | 136 | Phase 3 | Belgium;Canada;Netherlands;Poland;Sweden;United States | |
| 43 | EUCTR2014-003796-32-DE | 21/08/2015 | 5 December 2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) who are not current users of growth hormone treatment to assess the efficacy, safety and tolerability of TV-1106 (experimental medicinal product) | A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment | Growth hormone deficiency MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available yet Current Sponsor code: TV-1106; Albutropin Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available yet Current Sponsor code: TV-1106; Albutropin Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Teva Pharmaceutical Industries Ltd. | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | |||
| 44 | EUCTR2014-002736-13-DE | 19/08/2015 | 5 December 2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available yet Current Sponsor code: TV-1106; Albutropin Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Current Sponsor code: Not applicable Other descriptive name: SOMATROPIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available yet Current Sponsor code: TV-1106; Albutropin Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Teva Pharmaceutical Industries Ltd. | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | |||
| 45 | NCT02413138 | August 8, 2015 | 11 June 2018 | Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317) | A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) | Pediatric Growth Hormone Deficiency;Growth Disorders | Drug: Somavaratan (VRS-317) | Versartis Inc. | Not recruiting | 3 Years | 10 Years | All | 41 | Phase 2/Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2015-001939-21-HU | 16/07/2015 | 13 February 2017 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Pharmaceutical Form: Solution for injection INN or Proposed INN: none Current Sponsor code: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Trade Name: Genotropin® Product Name: Genotropin® Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12- Pharmaceutical Form: Solution for injection INN or Proposed INN: none Current Sponsor code: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Trade Name: Genotropin® Product Name: Genotropin® Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12- Pharmaceutical Form: Solution for injection INN or Proposed INN: none Current Sponsor code: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Trade Name: Genotropin® Product Name: Genotropin® Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12- | Genexine, Inc. | Authorised | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of | |||
| 47 | NCT02526420 | July 2015 | 21 November 2016 | Versartis International Trial in Adults With Long-Acting Growth Hormone | An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD) | Adult Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | Premier Research Group plc | Not recruiting | 23 Years | 70 Years | Both | 36 | Phase 2 | United States;Australia;Germany;United Kingdom |
| 48 | NCT02410356 | April 30, 2015 | 11 June 2018 | Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD) | A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (dGH) in Adults With Growth Hormone-Deficiency | Growth Hormone Deficiency | Drug: TV-1106;Drug: dGH | Teva Pharmaceutical Industries, Ltd. | Not recruiting | 18 Years | N/A | All | 34 | Phase 3 | United States;Argentina;Austria;Czechia;Greece;Hungary;Italy;Mexico;Slovakia;Spain;Ukraine;Brazil;Bulgaria;Canada;Chile;Croatia;Czech Republic;France;Georgia;Germany;Israel;Lithuania;Peru;Poland;Romania;Russian Federation;Serbia;Slovenia;Sweden;Turkey | |
| 49 | EUCTR2014-004525-41-SE | 10/04/2015 | 30 October 2017 | A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 19.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan (VRS-317) Pharmaceutical Form: Injection INN or Proposed INN: VRS-317 CAS Number: 1448335-08-7 Other descriptive name: VRS-317 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Concentration number: 25-34 Pharmaceutical Form: Injection INN or Proposed INN: Recombinat human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Concentration unit: µg/kg microgram(s)/kilogram Concentration type: equal Concentration number: 34- | Versartis, Inc. | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | |||
| 50 | NCT02311894 | March 31, 2015 | 20 August 2018 | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency | A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY) | Growth Hormone Deficiency | Drug: Somatropin | Genentech, Inc. | Not recruiting | 3 Years | 14 Years | All | 82 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2014-002698-13-SE | 03/02/2015 | 22 May 2017 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Pharmaceutical Form: Solution for injection Current Sponsor code: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Trade Name: Genotropin® Product Name: Genotropin® Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: Genotropin® Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- | Genexine, Inc | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | |||
| 52 | EUCTR2014-002698-13-SK | 14/01/2015 | 3 April 2017 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Trade Name: Genotropin® Product Name: Genotropin® Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: Genotropin® Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- | Genexine, Inc | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | |||
| 53 | NCT02360046 | January 2015 | 22 October 2018 | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism | The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind Trial | Hypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin Sensitivity | Drug: Hydrocortisone;Drug: Placebo | University Hospital Inselspital, Berne | Not recruiting | 18 Years | N/A | All | 30 | N/A | Switzerland | |
| 54 | NCT02418767 | January 2015 | 14 October 2019 | Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Single Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Doses of Long Acting HGH Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers | Growth Hormone Deficiency | Drug: MOD-4023;Drug: Placebo | OPKO Health, Inc. | WCCT Global | Not recruiting | 18 Years | 45 Years | Male | 42 | Phase 1 | United States |
| 55 | NCT02946606 | January 2015 | 16 December 2017 | A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 | A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | Not recruiting | 20 Years | 65 Years | All | 45 | Phase 2 | Korea, Republic of | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT02976675 | January 2015 | 16 December 2017 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Suzhou Municipal Hospital;General Hospital of Ningxia Medical University;The First Affiliated Hospital of Henan University of Science and Technology;Maternal and Child Health Hospital of Hubei Province;Nantong University | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China |
| 57 | NCT03249480 | January 2015 | 16 December 2017 | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency | Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Beijing Children's Hospital;Tianjin Medical University General Hospital;Peking University Third Hospital;China-Japan Friendship Hospital;Dalian Children's Hospital;Xi'an Children's Hospital;Wuhan Children's Hospital;Fuzhou Children s Hospital;Anhui Provincial Children's Hospital;Hunan Children's Hospital;Shenzhen Children's Hospital;Children's Hospital of Hebei Province;Second Affiliated Hospital of Xi'an Jiaotong University;Children's Hospital of Zhengzhou;Children's Hospital Of Soochow University;Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region;The First Affiliated Hospital of Kunming Medical College;Kunming Children's Hospital;The First People's Hospital of Yunnan;Xuzhou Children's Hopspital;Henan Provincal People's Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;First Affiliated Hospital of Harbin Medical University;The Second Hospital of Hebei Medical University;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;Union Hospital of Tongji Medical College of HUST;Wuxi Children's Hospital;The Second Affiliated Hospital of Kunming Medical University;Nanjing Children's Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 58 | NCT02380235 | December 2014 | 16 December 2017 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Recruiting | 3 Years | 18 Years | All | 600 | Phase 4 | China | ||
| 59 | EUCTR2013-002892-16-GB | 20/11/2014 | 28 February 2019 | A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency | A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1 | Growth hormone deficiency in adults MedDRA version: 19.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- Pharmaceutical form of the placebo: Solution for injection in pre-filled pen Route of administration of the placebo: Subcutaneous use Trade Name: Norditropin FlexPro 10 mg Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden | |||
| 60 | EUCTR2014-000290-39-SE | 07/11/2014 | 11 April 2016 | A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency | A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency - REAL 2 | Growth hormone deficiency in adults MedDRA version: 17.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- Trade Name: Norditropin FlexPro 10 mg Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 90 | European Union;Denmark;United Kingdom;Japan;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT02314676 | November 2014 | 19 February 2015 | Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Dwarfism, Pituitary | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Recruiting | 3 Years | N/A | Both | 900 | Phase 4 | China | ||
| 62 | NCT02908958 | November 2014 | 16 December 2017 | Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency | Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | The Children's Hospital of Zhejiang University School of Medicine;The Second Hospital of Anhui Medical University;Guangzhou Women and Children's Medical Center;First People's Hospital of Hangzhou;Qilu Hospital of Shandong University;Zhejiang Provincial People’s Hospital;Zhejiang Provincial Hospital of TCM;Central South University;Southwest Hospital, China;First Affiliated Hospital of Guangxi Medical University;Shanghai Children's Medical Center;Second Affiliated Hospital of Wenzhou Medical University;The First Affiliated Hospital of Xiamen University;Third Affiliated Hospital, Sun Yat-Sen University;Xiangya Hospital of Central South University;Shaoxing Second Hospital | Recruiting | 3 Years | 18 Years | All | 900 | Phase 4 | China |
| 63 | NCT02229851 | October 31, 2014 | 15 July 2019 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: somatropin;Drug: placebo | Novo Nordisk A/S | Not recruiting | 23 Years | 79 Years | All | 301 | Phase 3 | United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom | |
| 64 | EUCTR2014-002039-32-DK | 02/09/2014 | 22 May 2017 | Fatigue in patients with adrenal insufficiency - a comparison of the effect of a new modified-release hydrocortisone, and conventional hydrocortisone. | PlenadrEMA study - Effect of modified-release compared to conventional hydrocortisone on fatigue, measured by Ecological Momentary Assessments; a pilot study to assess feasibility, responsiveness of outcomes and to inform power calculations for future large-scale RCTs - PlenadrEMA study | Secondary adrenal insufficiency due to hypopituitarism MedDRA version: 20.0 Level: LLT Classification code 10052382 Term: Secondary adrenal insufficiency System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Plenadren 5 mg modified-release tablets Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Hydrocortisone TAKEDA, tabletter Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Product Name: Hydrokortison Glostrup 5 mg Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Plenadren 20 mg modified-release tablets Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Rigshospitalet, Copenhagen University Hospital | Authorised | Female: yes Male: yes | Phase 4 | Denmark | ||||
| 65 | NCT02243852 | September 2014 | 19 February 2015 | Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) | Evaluation of the Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) Concentration in Patients With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency | Drug: Growth Hormone Replacement Therapy | University of Liverpool | Pfizer | Recruiting | 18 Years | 80 Years | Both | 48 | N/A | United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT02018172 | July 2014 | 25 May 2015 | Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device | Growth Hormone Deficiency;Turner's Syndrome | Drug: somatropin | Ferring Pharmaceuticals | Not recruiting | N/A | N/A | Both | 3 | N/A | France | ||
| 67 | EUCTR2013-004468-69-HU | 11/06/2014 | 23 May 2016 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 17.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Albutropin Current Sponsor code: TV1106 Other descriptive name: human Serum Albumin (HSA) fused to somatropin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Albutropin Current Sponsor code: TV-1106 Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: n/a Other descriptive name: SOMATROPIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- | Teva Pharmaceutical Industries, Ltd. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia | |||
| 68 | NCT02092077 | April 30, 2014 | 11 June 2018 | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth Hormone-Deficiency | Drug: TV-1106;Drug: somatropin | Teva Pharmaceutical Industries, Ltd. | Not recruiting | 3 Years | 11 Years | All | 65 | Phase 2 | Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia | |
| 69 | NCT02068521 | March 3, 2014 | 11 June 2018 | Versartis Long-Term Safety Study of Somavaratan | An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency | Pediatric Growth Hormone Deficiency | Drug: somavaratan | Versartis Inc. | Not recruiting | 3 Years | N/A | All | 385 | Phase 2/Phase 3 | United States | |
| 70 | NCT02507245 | January 2014 | 3 August 2015 | Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD) | Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD) | Growth Hormone Deficiency | Drug: Growth Hormone-Releasing Hormone | Stefania La Grutta, MD | Not recruiting | 5 Years | 15 Years | Both | 48 | N/A | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT01973244 | December 16, 2013 | 11 June 2018 | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somapacitan;Drug: somatropin | Novo Nordisk A/S | Not recruiting | 6 Years | 13 Years | All | 32 | Phase 1 | Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland | |
| 72 | EUCTR2013-000013-20-SI | 09/12/2013 | 10 July 2015 | A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency | Growth hormone deficiency in children MedDRA version: 14.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: n/a CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- Trade Name: Norditropin SimpleXx 10 mg Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Other descriptive name: SOMATROPIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 32 | European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden | ||||
| 73 | EUCTR2013-000830-37-HU | 03/07/2013 | 26 November 2018 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: na CAS Number: na Current Sponsor code: MOD-4023 Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: na CAS Number: na Current Sponsor code: MOD-4023 Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: na CAS Number: na Current Sponsor code: MOD-4023 Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | OPKO Biologics Ltd. | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | |||
| 74 | NCT01947907 | July 2013 | 19 October 2017 | Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: ACP-001;Drug: Human Growth Hormone | Ascendis Pharma A/S | Not recruiting | 3 Years | 12 Years | All | 53 | Phase 2 | Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine | |
| 75 | NCT01909479 | June 2013 | 3 September 2018 | A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting Hgh Product (Mod-4023) In Adult Subjects With Growth Hormone Deficiency | A PHASE 3, MULTICENTER STUDY DESIGNED TO EVALUATE THE EFFICACY AND SAFETY OF A LONG ACTING HGH PRODUCT (MOD-4023) IN ADULT SUBJECTS WITH GROWTH HORMONE DEFICIENCY | Adult Growth Hormone Deficiency | Drug: MOD-4023;Other: Placebo | Opko Biologics | Not recruiting | 23 Years | 70 Years | All | 189 | Phase 3 | Israel;United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2012-005066-36-NL | 15/05/2013 | 20 May 2013 | To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency | Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors | Growth hormone deficiency;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Genotropin Pharmaceutical Form: Concentrate and solvent for solution for injection Trade Name: Norditropin Pharmaceutical Form: Concentrate and solvent for solution for injection Trade Name: Humatrope Pharmaceutical Form: Concentrate and solvent for solution for injection Trade Name: Zomacton Pharmaceutical Form: Concentrate and solvent for solution for injection | VU University Medical Center | Authorised | Female: yes Male: yes | Netherlands | |||||
| 77 | NCT01811576 | March 31, 2013 | 11 June 2018 | Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: TV-1106;Drug: Recombinant human growth hormone | Teva Pharmaceutical Industries, Ltd. | Not recruiting | 23 Years | 65 Years | All | 52 | Phase 2 | United States;Czechia;Germany;Greece;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic;Sweden | |
| 78 | EUCTR2012-004263-47-GB | 01/03/2013 | 3 November 2014 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN Pharmaceutical Form: Solution for injection | Merck KGaA | Authorised | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | |||
| 79 | NCT01494779 | March 2013 | 19 February 2015 | Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A. | GH Deficiency (GHD);Growth Retardation | Drug: Somatropin | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | Not recruiting | 18 Years | 32 Years | Male | 32 | Phase 1 | Brazil | ||
| 80 | EUCTR2012-002787-27-HU | 11/02/2013 | 28 September 2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: somatropin Current Sponsor code: TransCon PEG hGH Other descriptive name: Transiently PEGylated hGH prodrug Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10.0- Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5.3- | Ascendis Pharma A/S | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT02500316 | February 2013 | 22 July 2019 | Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children | Growth Hormone Deficiency (GHD) | Drug: MOD-4023 | Opko Biologics | Not recruiting | 3 Years | 11 Years | All | 48 | Phase 2 | United States;Belarus;Greece;Hungary;Russian Federation;Ukraine;Slovakia | |
| 82 | EUCTR2012-004975-37-HU | 21/01/2013 | 31 August 2015 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Albutropin Current Sponsor code: TV-1106 Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: Albutropin Product Code: TV-1106 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Albutropin Current Sponsor code: TV-1106 Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: n/a Other descriptive name: SOMATROPIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5,3- | Teva Pharmaceutical Industries Ltd. | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden | |||
| 83 | NCT01731028 | January 2013 | 19 February 2015 | Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton® | Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice | Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | Not recruiting | 3 Years | 18 Years | Both | 0 | N/A | ||
| 84 | NCT01775358 | January 2013 | 19 February 2015 | Phase 1 Safety Study of ALRN-5281 in Healthy Subjects | A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers | Growth Hormone Deficiency | Drug: ALRN-5281 0.015 mg/kg;Drug: ALRN-5281 0.05 mg/kg;Drug: ALRN-5281 0.15 mg/kg;Drug: Placebo 0.015 mg/kg;Drug: Placebo 0.05mg/kg;Drug: Placebo 0.15mg/kg | Aileron Therapeutics | Not recruiting | 20 Years | 50 Years | Both | 33 | Phase 1 | United States | |
| 85 | NCT01901666 | January 2013 | 19 February 2015 | Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In Remission | ASSESSMENT OF GH-IGF1 AXIS AND TO STUDY RESPONSE TO GH THERAPY IN CHILDREN WITH CML IN REMISSION HAVING GH DEFICIENCY | Chronic Myelogenous Leukemia;Short Stature | Drug: Growth Hormone | Postgraduate Institute of Medical Education and Research | Recruiting | N/A | N/A | Both | 20 | Phase 4 | India | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT01706783 | October 12, 2012 | 11 June 2018 | A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somapacitan;Drug: Norditropin NordiFlex® | Novo Nordisk A/S | Not recruiting | 20 Years | 70 Years | All | 35 | Phase 1 | Denmark;Sweden | |
| 87 | NCT01718041 | October 2012 | 15 August 2016 | Versartis Trial in Children to Assess Long-Acting Growth Hormone | A Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children With Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy After Subcutaneous Administration for 6 Months | Pediatric Growth Hormone Deficiency | Drug: Experimental: VRS-317 | Versartis Inc. | Not recruiting | 3 Years | 11 Years | Both | 64 | Phase 1/Phase 2 | United States | |
| 88 | EUCTR2011-005377-23-ES | 18/07/2012 | 29 May 2017 | Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD). | A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD). | Spinal Cord Injury and Growth Hormone Deficiency MedDRA version: 14.1 Level: PT Classification code 10041558 Term: Spinal cord injury thoracic System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: PT Classification code 10041554 Term: Spinal cord injury cervical System Organ Class: 10022117 - Injury, poisoning and procedural complications ;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Trade Name: NUTROPIN Product Name: NutropinAq 10 mg/2 ml (30 UI) Pharmaceutical Form: Solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: up to Concentration number: 0.0125- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Guillem Cuatrecasas Cambra | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain | |||
| 89 | NCT01209416 | June 2012 | 16 December 2017 | The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin | The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin | Metabolism;Insulin Resistance;Hypopituitarism | Drug: Acipimox;Drug: Ghrelin;Other: Placebo | University of Aarhus | Not recruiting | 18 Years | 65 Years | Male | 8 | N/A | Denmark | |
| 90 | NCT01574859 | April 2012 | 19 February 2015 | Central Hypothyroidism and Cardiovascular Risk | Central Hypothyroidism and Cardiovascular Risk Factors | Hypopituitarism | Other: levothyroxine | Rigshospitalet, Denmark | Not recruiting | N/A | N/A | Both | 200 | N/A | Denmark | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT01514500 | January 16, 2012 | 11 June 2018 | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;Healthy | Drug: somapacitan;Drug: placebo (somapacitan) | Novo Nordisk A/S | Not recruiting | 20 Years | 45 Years | Male | 105 | Phase 1 | Germany | |
| 92 | EUCTR2011-004553-60-HU | 10/01/2012 | 6 February 2017 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children | Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: not available Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection INN or Proposed INN: not available Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5.3- | OPKO Biologics Ltd. | Authorised | Female: yes Male: yes | 56 | Phase 2 | Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation | |||
| 93 | NCT01822340 | October 2011 | 14 March 2016 | Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients | A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: HM10560A;Drug: Genotropin | Hanmi Pharmaceutical Company Limited | Not recruiting | 23 Years | 60 Years | Both | 72 | Phase 2 | Hungary;Romania | |
| 94 | NCT01440686 | September 2011 | 19 February 2015 | Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers | A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | HanAll BioPharma Co., Ltd. | Not recruiting | 19 Years | 50 Years | Male | 40 | Phase 1 | Korea, Republic of | |
| 95 | EUCTR2011-000460-10-GB | 03/08/2011 | 3 December 2012 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated genetic markers validation Phase IV open-label study in Growth Hormone Deficient and Turner Syndrome pre-pubertal children : the PREDICT Pharmacogenetics Validation Study - PREDICT PGx Validation Study | idiopathic growth hormone deficienty Turner Syndrome MedDRA version: 13.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1 Level: PT Classification code 10045181 Term: Turner's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: Saizen 8mg click.easy powder for solution for injection Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: somatropin Current Sponsor code: NA Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5.83- | Merck Serono SA | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | United Kingdom;Italy;Russian Federation;Spain;Canada;Czech Republic | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT01467193 | August 2011 | 22 October 2018 | The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. | The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. | Ectopic Lipids;Insulin Sensitivity;Aerobic Exercise;Fat Load;Growth Hormone Deficiency | Dietary Supplement: Fat diet;Other: 2h standardized aerobic exercise | University Hospital Inselspital, Berne | Swiss National Science Foundation | Not recruiting | 18 Years | 80 Years | All | 30 | Phase 3 | Switzerland |
| 97 | EUCTR2011-001826-61-HU | 29/07/2011 | 31 August 2015 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Pharmaceutical Form: Solution for injection Current Sponsor code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 19.5- Trade Name: Genotropin Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5.3- | Hanmi Pharmaceutical Co., Ltd. | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | India;Korea, Republic of;Bulgaria;Russian Federation;Romania;Ukraine;Poland;Hungary;Serbia | |||
| 98 | NCT01237041 | July 1, 2011 | 18 December 2018 | Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children | Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children | Obesity;Short Stature;Growth Hormone Deficiency | Drug: Niacin First;Drug: Placebo First;Drug: Dose-Establishing Study 1 Niacin 250mg;Drug: Dose-Establishing Study 1 Niacin 500mg;Drug: Dose-Establishing Study 2 Niacin 500mg | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 7 Years | 14 Years | All | 37 | Phase 1/Phase 2 | United States | |
| 99 | EUCTR2009-017011-16-SE | 16/06/2011 | 18 September 2012 | Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study | Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study | Low serum IGF-I and GH deficiency in patients with congestive heart failure;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Saizen Product Name: Saizen Pharmaceutical Form: Concentrate and solvent for injection | University Federico II | Not Recruiting | Female: no Male: no | Sweden | |||||
| 100 | EUCTR2010-020742-10-GB | 09/05/2011 | 19 March 2012 | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGH Dose Therapy. | Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Year of Growth Hormone Therapy: A Phase II, Prospective, Randomized, Open-label, Multi-Centre, Parallel Group Add-On Study Comparing a Flexible rhIGF-1 Dose and Fixed rhGH Dose vs. Fixed rhGH Dose Therapy. | Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Trade Name: NutropinAq 10 mg/2 ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trade Name: INCRELEX 10 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Mecasermin CAS Number: 67763-96-6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: NutropinAq 10 mg/2 ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | Ipsen Pharma | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | Finland;United Kingdom;Spain;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT01327924 | April 2011 | 19 February 2015 | Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone | Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome;Foetal Growth Problem;Small for Gestational Age;Chronic Kidney Disease;Chronic Renal Insufficiency;Delivery Systems | Drug: Norditropin NordiFlex® | Novo Nordisk A/S | Not recruiting | N/A | 16 Years | Both | 77 | N/A | France | |
| 102 | NCT01359488 | March 2011 | 19 February 2015 | VRS-317 in Adult Subjects With Growth Hormone Deficiency | A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: VRS-317 | Versartis Inc. | Not recruiting | 25 Years | 65 Years | Both | 50 | Phase 1 | United States | |
| 103 | NCT01804413 | March 2011 | 19 February 2015 | Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency | Effects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot Study | Adults Growth Hormone Deficiency. | Drug: Pegvisomant;Drug: Regular insulin | Oregon Health and Science University | Aarhus University Hospital | Recruiting | 21 Years | 55 Years | Both | 10 | N/A | United States |
| 104 | EUCTR2010-023430-23-HU | 17/01/2011 | 25 September 2012 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 6-12 | Merck Serono S.A. | Not Recruiting | Female: yes Male: yes | 50 | Phase 3b | Hungary;United Kingdom;Czech Republic | ||||
| 105 | NCT01282164 | January 2011 | 16 December 2017 | The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis | The Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal Axis | Adult Growth Hormone Deficiency;Hypothalamic-pituitary Disorders | Procedure: Glucagon stimulation test and insulin tolerance test;Procedure: glucagon stimulation test and insulin tolerance test | The Cleveland Clinic | Massachusetts General Hospital;Allegheny Endocrinology Associates;Oregon Health and Science University | Not recruiting | 18 Years | 80 Years | All | 43 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT01243892 | November 2010 | 19 October 2017 | A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device | A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin® | Growth Hormone Deficiency | Device: NuSpin;Drug: Somatropin | Genentech, Inc. | Not recruiting | 2 Years | 14 Years | All | 18 | N/A | United States | |
| 107 | NCT01247675 | November 2010 | 16 December 2017 | A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: ACP-001 (TransCon hGH);Drug: Omnitrope | Ascendis Pharma A/S | Not recruiting | 20 Years | 70 Years | All | 37 | Phase 2 | Denmark;Germany;Italy;Sweden | |
| 108 | EUCTR2009-017354-12-SE | 11/10/2010 | 31 July 2012 | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | A MULTICENTER, OPEN-LABEL, RANDOMIZED, TWO ARM CROSS-OVER STUDY ASSESSING DYAD (SUBJECT AND CAREGIVER) AND ADULT SUBJECT PERCEPTION OF CONVENIENCE AND PREFERENCE OF THE NEWLY DEVELOPED GENOTROPIN MARK VII PEN | Subjects with Growth Hormone Deficiency MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Name: Genotropin Mark VII pen Product Code: PN-180307 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: n/a Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Genotropin Mark VII pen Product Code: PN-180307 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: n/a Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Product Name: Genotropin Mark VII pen Product Code: PN-180307 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: n/a Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Current Sponsor code: Genotropin Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12- | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Czech Republic;Sweden | ||||
| 109 | NCT01090778 | October 2010 | 19 February 2015 | Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) | Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Norditropin SimpleXx (growth hormone) | Aarhus University Hospital | Novo Nordisk A/S | Not recruiting | 18 Years | 75 Years | Both | 8 | Phase 2 | Denmark |
| 110 | NCT01237340 | October 2010 | 19 October 2017 | Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study | A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: Saizen® | EMD Serono | Not recruiting | 18 Years | 60 Years | All | 59 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | EUCTR2010-021523-28-AT | 02/09/2010 | 19 November 2012 | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency MedDRA version: 12.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency | Product Name: ACP-001 Product Code: ACP-001 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 32- Trade Name: Omnitrope® Pharmaceutical Form: Solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 3.3- | Ascendis Pharma A/S | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Denmark;Austria;Germany;Italy;Sweden | |||
| 112 | NCT01225666 | August 2010 | 14 October 2019 | MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Adult Growth Hormone Deficiency | Drug: MOD-4023 | OPKO Health, Inc. | Not recruiting | 23 Years | 60 Years | All | 52 | Phase 2 | Czechia;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic | |
| 113 | EUCTR2010-019374-32-SK | 15/07/2010 | 7 August 2012 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Pharmaceutical Form: Solution for injection Current Sponsor code: MOD-4023 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5,3-13.8 Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 1.9-7.6 Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 3,33-10 Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5,83- Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 | ModigeneTech Ltd. | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | |||
| 114 | EUCTR2010-019735-35-FR | 14/06/2010 | 19 March 2012 | Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien | Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien | Déficit somatotrope de l'adulte consécutif à un traumatisme crânien MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Trade Name: Nutropin Aq Product Name: NutropinAq Pharmaceutical Form: Solution for injection | CHU Amiens | Authorised | Female: yes Male: yes | France | |||||
| 115 | EUCTR2010-019296-30-GB | 18/05/2010 | 25 September 2012 | A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degree relatives. - ALS deficiency: insulin resistance, bone strength & response to rhIGF1 | ALS (acid label subunit) deficiency MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth Hormone Deficiency | Trade Name: INCRELEX Product Name: Increlex Pharmaceutical Form: Solution for injection | University Hospital Birmingham NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | NCT01613573 | March 2010 | 19 February 2015 | Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children | A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children | Growth Hormone Deficiency | Drug: somatropin AQ;Drug: pegylated somatropin | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology | Not recruiting | 4 Years | 10 Years | Male | 12 | Phase 1 | |
| 117 | EUCTR2009-016783-37-SE | 07/01/2010 | 19 March 2012 | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | Growth hormone deficiency in adults | Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 Pharmaceutical Form: Cutaneous solution INN or Proposed INN: recombinant human growth hormone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1 mg-0.5 mg | Sahlgrenska University Hospital | Authorised | Female: yes Male: yes | 60 | Sweden | ||||
| 118 | NCT00884000 | January 2010 | 19 February 2015 | A Study of Zomacton in Children With Growth Hormone Deficiency | A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Genotropin;Drug: Zomacton | Ferring Pharmaceuticals | Not recruiting | 3 Years | 11 Years | Both | 165 | Phase 3 | Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine | |
| 119 | EUCTR2010-018781-23-NL | 2 October 2017 | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate growth hormone deficiency (GHD) and non-GHD. To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency of side effects in the different tests (arginine, clonidine, protein). MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Name: Gelatin Product Code: 3 Pharmaceutical Form: Powder for oral solution Product Name: Arginin Product Code: 1 Pharmaceutical Form: Injection* Trade Name: Clonidine HCl CF 0,150 mg, tabletten Product Name: Clonidine Product Code: 2 Pharmaceutical Form: Tablet INN or Proposed INN: Clonidin CAS Number: 4205-91-8 Other descriptive name: CLONIDINE HYDROCHLORIDE Concentration unit: mg/m2 milligram(s)/square meter Concentration type: up to Concentration number: 0.15- | Top Institute Food and Nutrition | Not Available | Female: yes Male: yes | Netherlands | ||||||
| 120 | NCT01605331 | December 2009 | 19 February 2015 | Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) | Growth Hormone Deficiency | Drug: sustained-release recombinant human GH (SR-rhGH) | LG Life Sciences | Not recruiting | 20 Years | N/A | Both | 132 | Phase 4 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | NCT01007071 | November 1, 2009 | 16 December 2017 | Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency | Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults | Hypopituitarism | Drug: Human Growth Hormone (1-134);Drug: Placebo | Stanford University | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | All | 11 | Phase 3 | United States |
| 122 | NCT01062529 | October 2009 | 19 February 2015 | Peripheral Metabolic Effects of Somatostatin | Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls | Acromegaly;Growth Hormone Deficiency;Diabetes | Drug: Somatostatin | University of Aarhus | The Ministry of Science, Technology and Innovation, Denmark | Not recruiting | 18 Years | 50 Years | Male | 8 | N/A | Denmark |
| 123 | NCT01109017 | October 2009 | 19 February 2015 | Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency | A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | N/A | Both | 387 | N/A | Japan | |
| 124 | EUCTR2008-008240-25-FR | 02/09/2009 | 19 March 2012 | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children | growth hormone deficiency (GHD) in children MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Code: NNC 126-0083 Pharmaceutical Form: Powder and solvent for solution for injection Current Sponsor code: NNC 126-0083 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.8- Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml Product Name: Norditropin NordiFlex® 10mg/1.5 ml Product Code: N/A Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7- | Novo Nordisk A/S | Authorised | Female: yes Male: yes | United Kingdom;Denmark;Slovenia;France;Spain | |||||
| 125 | EUCTR2009-010918-30-IE | 11/08/2009 | 19 March 2012 | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care. MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10033662 Term: Panhypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency MedDRA version: 9.1 Level: LLT Classification code 10011318 Term: Craniopharyngioma MedDRA version: 9.1 Level: LLT Classification code 10036832 Term: Prolactinoma MedDRA version: 9.1 Level: LLT Classification code 10011651 Term: Cushing's disease MedDRA version: 9.1 Level: LLT Classification code 10035104 Term: Pituitary tumour MedDRA version: 9.1 Level: LLT Classification code 10061538 Term: Pituitary tumour benign | Trade Name: Genotropin 5.3mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 5.3- Trade Name: Genotropin 12mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 12- Trade Name: Genotropin Miniquick 0.2mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.2- Trade Name: Genotropin Miniquick 0.4mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.4- Trade Name: Genotropin Miniquick 0.6mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.6- Trade Name: Genotropin Miniquick 0.8mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.8- Trade Name: Genotropin Miniquick 1.0mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Trade Name: Genotropin Miniquick 1.2mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.2- | Amar Agha, Beaumont Hospital | Authorised | Female: yes Male: yes | 20 | Ireland | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT00934063 | July 2009 | 11 May 2015 | An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® | A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin) | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Other: No treatment given | Novo Nordisk A/S | Not recruiting | 18 Years | N/A | Both | 121 | N/A | Germany | |
| 127 | EUCTR2008-001674-32-FI | 29/04/2009 | 16 October 2017 | NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS | NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS | Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency MedDRA version: 16.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders | Trade Name: Norditropin Pharmaceutical Form: Injection INN or Proposed INN: somatotropine | Novo Nordisk Farma Oy | Not Recruiting | Female: yes Male: yes | 17000 | Phase 4 | Finland | |||
| 128 | NCT00837863 | March 2009 | 19 February 2015 | Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency | A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Altus Pharmaceuticals | Recruiting | 3 Years | 13 Years | Both | 36 | Phase 2 | United States | |
| 129 | NCT01298180 | January 2009 | 8 June 2015 | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Prader-Willi Syndrome;Growth Hormone Deficiency | Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsy | University Hospital, Toulouse | Not recruiting | 1 Year | 5 Years | Both | 111 | Phase 4 | France | |
| 130 | NCT00851942 | September 2008 | 16 December 2017 | Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test | Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test | Healthy;Adrenal Insufficiency;Hypopituitarism | Drug: Synacthen (Tetracosactrin) | Cardiff University | Not recruiting | 18 Years | 80 Years | All | 165 | Phase 4 | United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | EUCTR2007-001746-40-HU | 25/08/2008 | 19 March 2012 | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Code: ARX201 Pharmaceutical Form: Powder for injection* Current Sponsor code: PEG-ahGH Other descriptive name: Pegylated recombinant human growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 13.2- | Ambrx, Inc., USA | Not Recruiting | Female: yes Male: yes | 45 | Phase 2b | Hungary | |||
| 132 | NCT00675506 | July 2008 | 16 December 2017 | Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese | Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity | Abdominal Obesity;Growth Hormone Deficiency | Drug: Growth hormone releasing hormone (GHRH) 1-44;Drug: Placebo | Massachusetts General Hospital | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | 55 Years | All | 60 | Phase 2 | United States |
| 133 | NCT01034735 | July 2008 | 19 February 2015 | r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial | Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers | Growth Failure;Growth Hormone Deficiency | Biological: r-hGH liquid (Saizen);Biological: r-hGH freeze-dried | EMD Serono | Not recruiting | 18 Years | 45 Years | Both | 30 | Phase 1 | Germany | |
| 134 | EUCTR2008-001061-29-DK | 17/06/2008 | 19 March 2012 | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD) | Growth hormone deficiency MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Name: NN8630 Product Code: NNC 126-0083 Pharmaceutical Form: Solution for injection Current Sponsor code: NNC 126-0083 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6,8- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 32 | Denmark | ||||
| 135 | NCT00630487 | May 2008 | 19 October 2017 | Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency | Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study) | Growth Hormone Deficiency | Drug: Placebo;Drug: Somatropin | Pfizer | Not recruiting | 18 Years | 65 Years | All | 9 | Phase 3 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | EUCTR2007-000056-14-GB | 03/03/2008 | 19 March 2012 | Determination of method-specific normal cortisol and adrenal hormone responses to the short Synacthen test - Short Synacthen test Study | Determination of method-specific normal cortisol and adrenal hormone responses to the short Synacthen test - Short Synacthen test Study | Normal, healthy volunteers to establish a reference range for the synacthen test, plus patients with hypoadrenalism/hypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10020936 Term: Hypoadrenalism MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism | Trade Name: Synacthen Pharmaceutical Form: Solution for injection | Cardiff University | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 137 | NCT00555009 | March 2008 | 19 October 2017 | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury | Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury. | Brain Injuries;Growth Hormone Deficiency | Drug: Genotropin;Drug: Placebo | Pfizer | Not recruiting | 18 Years | 55 Years | All | 10 | Phase 4 | France;Italy;Netherlands;Spain;Sweden;United Kingdom | |
| 138 | NCT00646815 | March 2008 | 19 February 2015 | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (genotropin) | University of Aarhus | Aarhus University Hospital | Not recruiting | 18 Years | 60 Years | Both | 24 | N/A | Denmark |
| 139 | NCT00666068 | February 2008 | 19 February 2015 | Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism | Effects of CRH on the Sleep in Patients With Hypopituitarism | Hypopituitarism | Other: corticotropin releasing hormone (CRH);Other: Placebo | Max-Planck-Institute of Psychiatry | Not recruiting | 18 Years | 75 Years | Both | 30 | N/A | Germany | |
| 140 | EUCTR2007-005018-37-IE | 18/01/2008 | 19 March 2012 | Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement | Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement | 10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients. 10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone. MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10033662 Term: Panhypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10057217 Term: Isolated ACTH deficiency | Trade Name: Hydrocortone Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone CAS Number: 50-23-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: Hydrocortisone CAS Number: 50-23-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Amar Agha | Authorised | Female: no Male: yes | 20 | Ireland | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | EUCTR2007-000790-36-DE | 08/01/2008 | 29 May 2012 | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study) - PRO ISO-GHD Study | Isolated Adult Growth Hormone Deficiency MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Trade Name: Genotropin 5 mg/ml Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Genotropin 5 mg/ml Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | Pfizer Pharma GmbH | Not Recruiting | Female: yes Male: yes | 50 | Germany | ||||
| 142 | NCT00684957 | January 2008 | 19 February 2015 | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1 | Columbia University | Tercica | Not recruiting | 25 Years | 65 Years | Male | 5 | N/A | United States |
| 143 | EUCTR2007-003586-41-NL | 17/12/2007 | 19 March 2012 | Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury - N/A | Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury - N/A | Growth hormone deficiency after traumatic brain injury MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Trade Name: Genotropin Product Name: Genotropin Pharmaceutical Form: Powder for solution for injection Current Sponsor code: Genotropin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Netherlands;France;Spain;Italy;Sweden | ||||
| 144 | NCT01365351 | December 1, 2007 | 16 December 2017 | Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON | Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Other: Growth hormone | Ferring Pharmaceuticals | Ferring Arzneimittel GmbH | Not recruiting | N/A | N/A | All | 1034 | N/A | Germany |
| 145 | NCT01306357 | September 2007 | 19 February 2015 | Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device | Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective | Turner's Syndrome;Human Growth Hormone Deficiency | Drug: Somatropin | Ferring Pharmaceuticals | Not recruiting | N/A | N/A | Both | 87 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | EUCTR2006-003678-82-NL | 10/07/2007 | 19 March 2012 | Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency | Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency | Clonidine is studied in the paediatric population, more specific children with short stature. It is used as a diagnostic tool to establish Growth Hormone reserve in routine practice. MedDRA version: 8.1 Level: LLT Classification code 10005573 Term: Blood growth hormone decreased | Trade Name: Catapresan Pharmaceutical Form: Solution for injection | Centre for Human Drug Research | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
| 147 | NCT00324064 | July 2007 | 19 February 2015 | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Growth Hormone Deficiency | Procedure: GHRH/arginine stimulation testing | Children's Mercy Hospital Kansas City | Not recruiting | 5 Years | 40 Years | Both | 90 | N/A | United States | |
| 148 | NCT00491582 | July 2007 | 19 February 2015 | The Effects of Growth Hormone (GH) on Lipid Depots | The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance | Growth Hormone Deficiency | Drug: Growth hormone replacement therapy in growth hormone deficient patients only. | University Hospital Inselspital, Berne | Swiss National Science Foundation | Not recruiting | 18 Years | 80 Years | Both | 34 | N/A | Switzerland |
| 149 | NCT00448747 | June 2007 | 16 December 2017 | Investigation of a New, Oral Growth Hormone Secretagogue, Macimorelin (AEZS-130) as a Growth Hormone Stimulation Test. | A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly ARD-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy | Diagnosis of Adult Growth Hormone Deficiency (AGDH) | Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRH | AEterna Zentaris | Not recruiting | 18 Years | N/A | All | 100 | Phase 3 | United States | |
| 150 | NCT00615953 | May 2007 | 19 February 2015 | American Norditropin Studies - Registry of Growth Hormone (GH) Patients | American Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149 | Growth Hormone Deficiency | Drug: Norditropin Growth Hormone | Duke University | Novo Nordisk A/S | Not recruiting | N/A | N/A | Both | 79 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT00432263 | April 2007 | 4 May 2015 | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury. | Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury | Brain Injuries | Drug: Genotropin (PN-180,307) Somatropin | Pfizer | Not recruiting | 18 Years | 55 Years | Both | 0 | Phase 4 | ||
| 152 | NCT00455260 | April 2007 | 19 February 2015 | A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ System | Teva Neuroscience, Inc. | Teva Pharmaceutical Industries;TransPharma Medical | Not recruiting | 20 Years | 60 Years | Both | 60 | Phase 1 | Israel;Ukraine |
| 153 | NCT00601419 | March 2007 | 19 October 2017 | Drug Use Investigation of Somatropin for GHD-ADULTS. | Drug Use Investigation of GENOTROPIN for GHD-ADULTS. | Dwarfism, Growth Hormone Deficiency | Drug: Somatropin | Pfizer | Not recruiting | N/A | N/A | All | 230 | N/A | ||
| 154 | NCT01187550 | March 2007 | 19 October 2017 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary | Drug: Recombinant human growth hormone (r-hGH) | Merck KGaA | Merck Serono Co., Ltd., China | Not recruiting | N/A | N/A | All | 214 | Phase 4 | |
| 155 | NCT01495468 | March 2007 | 16 December 2017 | Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children | Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical Trial | Growth Hormone Deficiency | Biological: PEG-somatropin | GeneScience Pharmaceuticals Co., Ltd. | Tongji Hospital;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University;First Hospital of Jilin University | Not recruiting | 8 Years | 15 Years | All | 343 | Phase 3 | China |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT00720902 | February 2007 | 19 February 2015 | Adult Growth Hormone Deficiency and Cardiovascular Risk | Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas | Growth Hormone Deficiency | Procedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsy | Columbia University | Not recruiting | 19 Years | 65 Years | Both | 8 | N/A | United States | |
| 157 | EUCTR2006-005442-37-NL | 08/01/2007 | 19 March 2012 | PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury | PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury | isolated growth hormone deficiency after traumatic brain injury | Trade Name: recombinant growth hormone Pharmaceutical Form: Solution for injection | University Medical Center St Radboud, department of neurology | Authorised | Female: yes Male: yes | Netherlands | |||||
| 158 | NCT01576861 | January 2007 | 19 February 2015 | Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure | Growth Hormone Deficiency;Chronic Heart Failure | Drug: Somatotropin | Federico II University | Not recruiting | 18 Years | 80 Years | Both | 28 | Phase 2 | Italy | ||
| 159 | EUCTR2006-001574-24-NL | 06/10/2006 | 19 March 2012 | Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency | Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency | Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries | Trade Name: Genotropin Product Name: genotropin Product Code: RVG 15790 or RVG 25480 Pharmaceutical Form: Concentrate for solution for injection | Radboud University Nijmegen Medical Centre, Department of Endocrinology | Authorised | Female: yes Male: yes | 30 | Netherlands | ||||
| 160 | EUCTR2006-002278-24-DE | 06/10/2006 | 19 March 2012 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Code: LB03002 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: LB03002 Other descriptive name: recombinant human growth hormone (rhGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2005-004316-73-GB | 23/08/2006 | 18 April 2012 | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity | Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan) | Product Name: strontium ranelate Product Code: strontium ranelate Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: strontium ranelate Other descriptive name: N/A Concentration number: N/A- Product Name: Phosphate sandoz Product Code: phosphate sandoz Pharmaceutical Form: Effervescent tablet INN or Proposed INN: phosphate sandoz Other descriptive name: N/A Concentration number: N/A- Product Name: growth hormone Product Code: growth hormone Pharmaceutical Form: Injection* INN or Proposed INN: growth hormone Other descriptive name: N/A Concentration number: N/A- | Royal Liverpool University hospital | Authorised | Female: yes Male: yes | 100 | United Kingdom | ||||
| 162 | NCT00596037 | August 2006 | 19 February 2015 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: Growth hormone - LB03002 | LG Life Sciences | BioPartners GmbH | Not recruiting | 23 Years | 70 Years | Both | 136 | Phase 3 | United States |
| 163 | NCT00308464 | July 2006 | 19 February 2015 | A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency | A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients | Growth Hormone Deficiency | Drug: PHA-794428 | Pfizer | Not recruiting | 18 Years | 65 Years | Both | 136 | Phase 2 | Belgium;Czech Republic;Denmark;France;Germany;Italy;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom | |
| 164 | EUCTR2005-005587-82-SE | 12/06/2006 | 19 March 2012 | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A | Adult Growth Hormone Deficiency MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency | Product Name: N/A Product Code: PHA-794,428 Pharmaceutical Form: Powder for injection* INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use Product Name: N/A Product Code: PHA-794,428 Pharmaceutical Form: Powder for injection* INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use | Pfizer AB;Pfizer Ltd | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden | ||||
| 165 | EUCTR2005-005593-79-GB | 02/06/2006 | 19 March 2012 | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency - N/A | Paediatric Growth Hormone Deficiency MedDRA version: 8.1 Level: LLT Classification code 10056438 | Product Name: N/A Product Code: PHA-794428 Pharmaceutical Form: Powder for injection* INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use Product Name: N/A Product Code: PHA-794428 Pharmaceutical Form: Powder for injection* INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: N/A Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Powder for injection* Route of administration of the placebo: Subcutaneous use | Pfizer Limited | Not Recruiting | Female: yes Male: yes | 32 | Germany;United Kingdom;Spain | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | EUCTR2005-005613-38-IE | 31/05/2006 | 19 March 2012 | Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk? | Assessment of platelet function in the hypopituitary population. Does hormone replacement therapy alter thrombotic risk? | Hypopituitarism refers to decreased secretion of pituitary hormones, which can result from diseases of the pituitary gland or from diseases of the hypothalamus, which cause diminished secretion of hypothalamic releasing hormones, thereby reducing secretion of the corresponding pituitary hormones. | Trade Name: Trisequens Pharmaceutical Form: Film-coated tablet Trade Name: Testogel Pharmaceutical Form: Gel Trade Name: Genotropin MiniQuick Pharmaceutical Form: Powder and solvent for solution for injection | Dr. Chris Thompson | Authorised | Female: yes Male: yes | 50 | Ireland | ||||
| 167 | NCT01342146 | May 2006 | 16 December 2017 | Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children | Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study | Growth Hormone Deficiency | Drug: pegylated Somatropin;Drug: Jintropin AQ | GeneScience Pharmaceuticals Co., Ltd. | Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan University | Not recruiting | N/A | N/A | All | 101 | Phase 2 | |
| 168 | NCT00294619 | April 2006 | 19 February 2015 | Treatment of Adults With Growth Hormone Deficiency | A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency. | Pituitary Disorders;Adult Growth Hormone Deficiency | Drug: growth hormone | LG Life Sciences | BioPartners GmbH | Not recruiting | 23 Years | 70 Years | Both | 147 | Phase 3 | United States |
| 169 | NCT00314938 | April 2006 | 19 February 2015 | A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency | A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: PHA-794428 | Pfizer | Not recruiting | 6 Years | 12 Years | Both | 32 | Phase 2 | Belgium;France;Germany;Israel;United Kingdom;Spain | |
| 170 | EUCTR2005-001315-22-AT | 09/03/2006 | 19 March 2012 | The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. | The effect of the cholinesterase inhibitor donepezil on organic and functional deficits related to growth hormone deficiency in old age. | We plan to study healthy aging subjects. | Trade Name: Aricept Product Name: Aricept Product Code: Donepezil Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Gastroenteral use | Ludwig Boltzmann Gesellschaft | Not Recruiting | Female: yes Male: yes | 80 | Austria | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | EUCTR2005-004478-26-SE | 13/01/2006 | 28 August 2012 | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines. | Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours. | Trade Name: Norditropin SimpleXx Product Name: Norditropin SimpleXx Pharmaceutical Form: Solution for injection INN or Proposed INN: somatropin Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0,3-0,6 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Karolinska universitetssjukhuset | Not Recruiting | Female: yes Male: yes | Sweden | |||||
| 172 | NCT00362063 | January 2006 | 16 December 2017 | 304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency | Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone (Nutropin) | Baylor College of Medicine | Genentech, Inc. | Not recruiting | 1 Month | 17 Years | All | 20 | N/A | United States |
| 173 | NCT00517062 | January 2006 | 19 February 2015 | Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates | Effects of Low Dose Growth Hormone (GH) Therapy on Insulin Sensitivity, Adipocyte Insulin-like Growth Factor-I (IGF-I) and IGF-I/Insulin Receptor Density and Regulation of Cortisol Metabolism in GH Deficient Adults | Growth Hormone Deficiency | Drug: Growth hormone (Genotropin);Drug: Placebo | Oregon Health and Science University | Not recruiting | 18 Years | 75 Years | Both | 16 | Phase 0 | United States | |
| 174 | EUCTR2005-000384-26-AT | 10/11/2005 | 29 April 2013 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0 Level: PT Classification code 10056438 | Product Code: LB03002 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: somatropin CAS Number: 12629-01-5 Current Sponsor code: LB03002 Other descriptive name: recombinant human growth hormone (rhGH) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Powder and solvent for suspension for injection Route of administration of the placebo: Subcutaneous use | LG Life Science Ltd. | BioPartners | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 175 | EUCTR2004-004292-11-SE | 06/10/2005 | 19 March 2012 | Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO | Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCO | This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design. | Trade Name: Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin) Product Name: Norditropin SimplexX Product Code: NA Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Endocrine Department, Sahlgrenska University Hospital | Authorised | Female: yes Male: yes | 60 | Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | NCT00139945 | October 2005 | 19 February 2015 | Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients | Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction | Hypopituitarism | Drug: Human acylated ghrelin | University of Aarhus | Not recruiting | 18 Years | 60 Years | Both | 8 | N/A | Denmark | |
| 177 | NCT00552487 | October 2005 | 19 February 2015 | Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis | Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis | Hashimoto Disease;Adrenal Insufficiency | Drug: synacthen | University of Wuerzburg | Not recruiting | 18 Years | N/A | Both | 62 | N/A | Germany | |
| 178 | NCT00149708 | September 2005 | 19 February 2015 | Consequence of Lifetime Isolated Growth Hormone Deficiency | Consequence of Lifetime Isolated Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: growth hormone administration for 6 months | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | Both | 400 | N/A | Brazil |
| 179 | NCT00271518 | September 2005 | 19 February 2015 | Treatment of Children With Insufficient Secretion of Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone | Growth Hormone Deficiency (GHD) | Drug: growth hormone (somatropin) | LG Life Sciences | BioPartners GmbH | Not recruiting | 3 Years | 11 Years | Both | 144 | Phase 3 | United States |
| 180 | NCT00397319 | August 2005 | 19 February 2015 | Growth Hormone's Effect on the Cardiovascular System | The Role of Growth Hormone in Cardiovascular Health | Growth Hormone Deficiency | Drug: Growth Hormone | Vanderbilt University | Pfizer;National Center for Research Resources (NCRR) | Not recruiting | 18 Years | 65 Years | Both | 26 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT00297713 | July 2005 | 19 February 2015 | Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | Adult Growth Hormone Deficiency | Drug: ALTU-238 | Altus Pharmaceuticals | Not recruiting | 18 Years | 60 Years | Both | 12 | Phase 2 | United States | |
| 182 | EUCTR2005-001658-25-BE | 16/06/2005 | 7 October 2014 | An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency. | An open label, two period crossover study to explore the safety, pharmacokinetics and pharmacodynamics of PHA-794428 after single subcutaneous injections in adult male patients with growth hormone deficiency. | AGHD Adult Growth Hormone Deficiency | Product Code: PHA-794428 Pharmaceutical Form: Powder for injection* Current Sponsor code: PHA-794428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Code: PHA-794428 Pharmaceutical Form: Powder for injection* Current Sponsor code: PHA-794428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Pfizer Global Research and Development | Not Recruiting | Female: no Male: yes | 8 | Belgium | ||||
| 183 | EUCTR2004-005184-15-GB | 24/05/2005 | 21 January 2013 | Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATS | Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATS | Central (secondary/tertiary) hypothyroidism (subclinical) | Trade Name: Levothyroxine Product Name: Levothyroxine Pharmaceutical Form: Capsule* INN or Proposed INN: Levothyroxine Concentration unit: µg microgram(s) Concentration type: range Concentration number: 25-100 Pharmaceutical form of the placebo: Capsule* | Christie Hospital NHS Trust | Not Recruiting | Female: yes Male: yes | 80 | United Kingdom | ||||
| 184 | NCT00187993 | May 2005 | 19 February 2015 | Growth Hormone Treatment of Young Growth Hormone-Deficient Adults | Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications. | Growth Hormone Deficiency | Drug: Growth hormone | University Hospital, Angers | Novo Nordisk A/S | Recruiting | 18 Years | 35 Years | Both | 30 | N/A | France |
| 185 | NCT00256126 | May 2005 | 19 February 2015 | Predictive Markers in GHD and TS Children Treated With SAIZEN® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN® | Growth Hormone Deficiency | Drug: Saizen | Merck KGaA | Not recruiting | 2 Years | 16 Years | Both | 318 | Phase 4 | Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT01351818 | May 2005 | 19 February 2015 | Adipocyte Function and Somtropin Deficiency | The Fayds Project: Adipocyte Function and Somtropin Deficiency | Growth Hormone Deficiency | Drug: Growth Hormone | Ferring Pharmaceuticals | Ferring SAU | Not recruiting | 5 Years | 12 Years | Both | 62 | N/A | Spain |
| 187 | NCT01604161 | May 2005 | 3 August 2015 | Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome | A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs. | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | N/A | Both | 2016 | N/A | Japan | |
| 188 | EUCTR2004-004835-72-GB | 12/01/2005 | 30 June 2014 | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL) | Growth hormone deficiency in adult life | Trade Name: Norditropin SimpleXx 5mg/1.5ml Product Name: Norditropin SimpleXx 5mg/1.5ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin Other descriptive name: Growth Hormone, GH Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3.33- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | University of Birmingham | University Hospital Birmingham Foundation NHS Trust | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom | |||
| 189 | NCT00109733 | January 2005 | 19 October 2017 | Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency | A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS) | Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism | Biological: recombinant human growth hormone | EMD Serono | Not recruiting | 13 Years | 25 Years | All | 31 | Phase 3 | United States | |
| 190 | NCT00163189 | January 2005 | 19 October 2017 | Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm | Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm | Growth Hormone Deficiency | Drug: Somatropin | Pfizer | Not recruiting | N/A | N/A | All | 98 | Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | NCT00212758 | January 2005 | 19 October 2017 | A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood | IGF-1 Generation Test in Children With Chronic Kidney Disease | Kidney Failure, Chronic;Growth Hormone Deficiency | Drug: Nutropin AQ | Oregon Health and Science University | Genentech, Inc. | Not recruiting | 2 Years | 18 Years | All | 17 | Phase 4 | United States |
| 192 | NCT00373386 | January 2005 | 19 February 2015 | Growth Hormone and Endothelial Function in Children | Growth Hormone and Endothelial Function in Children | Growth Hormone Deficiency;Panhypopituitarism;Short Stature | Drug: growth hormone | Ohio State University | Nationwide Children's Hospital | Not recruiting | 8 Years | 18 Years | Both | 12 | Phase 4 | United States |
| 193 | NCT00140413 | December 2004 | 19 October 2017 | Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia | Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia | Growth Hormone Deficiency;Septo-Optic Dysplasia;Hypopituitarism | Drug: Nutropin AQ | Children's Hospital Los Angeles | Genentech, Inc. | Not recruiting | N/A | 5 Years | All | 20 | Phase 4 | United States |
| 194 | NCT00468624 | December 2004 | 19 February 2015 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) | Severe Adult Growth Hormone Deficiency | Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limb | Christie Hospital NHS Foundation Trust | Not recruiting | 18 Years | 70 Years | Both | N/A | United Kingdom | ||
| 195 | NCT00591760 | December 2004 | 19 October 2017 | Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial | Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study | Heart Failure;Growth Hormone Deficiency;Ischemic Heart Disease | Drug: Somatotropin | Federico II University | Not recruiting | 18 Years | 80 Years | All | 56 | Phase 2 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | EUCTR2004-002056-34-GB | 10/11/2004 | 21 August 2012 | Glucocorticosteroid replacement therapy and fibrinolysis in hypopituitarism - Glucocorticoid replacement therapy and fibrinolysis | Glucocorticosteroid replacement therapy and fibrinolysis in hypopituitarism - Glucocorticoid replacement therapy and fibrinolysis | Hypopituitarism | Trade Name: Hydrocortone Product Name: Hydrocortone Product Code: N/A Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Hydrocortone Product Name: Hydrocortone Product Code: N/A Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Bradford Teaching Hospitals NHS Foundation Trust | Authorised | Female: yes Male: yes | 15 | United Kingdom | ||||
| 197 | NCT00184730 | November 2004 | 28 November 2016 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of hGH in Long Term (More Than 48 Weeks) in GHDA. | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 19 Years | 67 Years | Both | 86 | Phase 3 | Japan | |
| 198 | EUCTR2004-002125-42-IT | 22/09/2004 | 19 March 2012 | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EVALUATION OF GROWTH HORMONE RELEASE | Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatorelin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.1- | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | Authorised | Female: yes Male: yes | Italy | |||||
| 199 | NCT00459940 | September 2004 | 19 February 2015 | The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients | Can Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists? | Growth Hormone Deficiency | Drug: Pioglitazone | University of Aarhus | Not recruiting | 19 Years | 71 Years | Male | 20 | N/A | Denmark | |
| 200 | NCT00182091 | August 2004 | 19 October 2017 | Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency | Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly | Acromegaly;Growth Hormone Deficiency;Pituitary Disease | Drug: Recombinant human growth hormone;Drug: Saline | Massachusetts General Hospital | Not recruiting | 18 Years | 85 Years | All | 75 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | NCT00489294 | August 2004 | 19 February 2015 | Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency | An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers | Growth Hormone Deficiency | Drug: Syntropin | Phage Pharmaceuticals, Inc. | Not recruiting | 18 Years | 45 Years | Both | 20 | Phase 1 | United States | |
| 202 | NCT00497562 | May 2004 | 19 February 2015 | Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) | Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia | Fibromyalgia;Growth Hormone Deficiency | Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group);Drug: amitriptyline, fluoxetine and tramadol alone (control group) | Centro Medico Teknon | Not recruiting | 18 Years | N/A | Both | Phase 2 | Spain | ||
| 203 | NCT00080483 | March 2004 | 19 October 2017 | Testosterone and Growth Hormone for Bone Loss in Men | Will Testosterone and Growth Hormone Improve Bone Structure? | Hypopituitarism;Hypogonadism;Growth Hormone Deficiency | Drug: Testosterone plus somatropin;Drug: testosterone | University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | Male | 35 | Phase 2 | United States |
| 204 | NCT00191165 | March 2004 | 19 October 2017 | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | Not recruiting | N/A | 14 Years | All | 27 | Phase 3 | Italy | |
| 205 | NCT00360074 | February 2004 | 19 February 2015 | Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation | A Randomised, Controlled, Crossover Study: Treatment With Thyroxin Compared to Thyroxin + Triiodothyronin in Patients With Secondary Hypothyroidism | Secondary Hypothyroidism;Hypopituitarism;Hyperlipidemias | Drug: Thyroxin, Triiodothyronine | University Hospital Freiburg | Not recruiting | 18 Years | 75 Years | Both | 25 | Phase 4 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | NCT00184743 | December 6, 2003 | 16 December 2017 | Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 48 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 18 Years | 65 Years | All | 112 | Phase 3 | Japan | |
| 207 | NCT00929799 | November 2003 | 19 February 2015 | Growth Hormone and Glucose Metabolism | Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: recombinant human Growth Hormone (Genotropin® ) | Charite University, Berlin, Germany | Not recruiting | 18 Years | N/A | Both | 6 | Phase 4 | Germany | |
| 208 | NCT00957671 | November 2003 | 11 June 2018 | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Growth Hormone Deficiency;Traumatic Brain Injury | Drug: Recombinant human growth hormone | The University of Texas Medical Branch, Galveston | The Moody Foundation | Not recruiting | 21 Years | N/A | All | 15 | Phase 4 | United States |
| 209 | NCT02693522 | October 2003 | 14 March 2016 | Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency | Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: somatropin;Drug: Eutropin | Daewoong Pharmaceutical Co. LTD. | Not recruiting | 18 Years | N/A | Both | 52 | Phase 3 | Korea, Republic of | |
| 210 | NCT01157793 | September 2003 | 19 February 2015 | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood | Dwarfism;Growth Hormone Deficiency | Drug: r-hGH | Merck KGaA | Not recruiting | 14 Years | 25 Years | Both | 34 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT00144391 | July 2003 | 16 December 2017 | Testosterone Gel Applied to Women With Pituitary Gland Problems | Physiologic Testosterone Replacement in Women With Hypopituitarism | Panhypopituitarism | Drug: Transdermal Testosterone gel | Charles Drew University of Medicine and Science | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 18 Years | 55 Years | Female | 20 | Phase 4 | United States |
| 212 | NCT01543880 | July 2003 | 11 May 2015 | Safety and Efficacy of Long-term Somatropin Treatment in Adults | Non-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in Adults | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 20 Years | N/A | Both | 752 | N/A | Germany | |
| 213 | NCT01580605 | July 2003 | 19 February 2015 | French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin | Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | N/A | Both | 331 | N/A | France | |
| 214 | NCT00476385 | June 2003 | 19 February 2015 | Practicability and Acceptability of Stylomax® in Children | Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children. | Growth Hormone Deficiency | Drug: somatropine | Sanofi | Not recruiting | 3 Years | 18 Years | Both | 12 | Phase 3 | France | |
| 215 | NCT00600808 | June 2003 | 19 February 2015 | Sustained Release Formulation of Somatropin (rDNA Origin)for Injection | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. | Growth Hormone Deficiency | Drug: BPLG-003 | BioPartners GmbH | LG Life Sciences | Not recruiting | 4 Years | 10 Years | Both | 51 | Phase 2/Phase 3 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | NCT00519558 | May 31, 2003 | 16 December 2017 | Growth Hormone Deficiency in Adults (GHDA) | Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 18 Years | 65 Years | All | 121 | Phase 3 | Japan | |
| 217 | NCT00567385 | March 10, 2003 | 16 December 2017 | Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 3 Years | 18 Years | All | 176 | Phase 4 | Turkey | |
| 218 | NCT00191360 | January 2003 | 19 February 2015 | Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency | Extended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone Deficiency | Adult Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | Not recruiting | 18 Years | 65 Years | Both | 68 | Phase 3 | Japan | |
| 219 | NCT00638053 | November 2002 | 19 February 2015 | A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury | Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury | Brain Injuries;Growth Hormone Deficiency Dwarfism | Genetic: somatropin | Pfizer | Not recruiting | 18 Years | N/A | Both | 100 | Phase 4 | United States | |
| 220 | NCT01088399 | September 2002 | 19 October 2017 | A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults | The Global Hypopituitary Control and Complications Study | Hypopituitarism;Pituitary Insufficiency;Growth Hormone Deficiency, Adult | Drug: Somatropin (rDNA origin) | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 10673 | N/A | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | NCT01009905 | June 24, 2002 | 16 December 2017 | An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) | Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone | Growth Hormone Disorder;Pituitary Dwarfism;Hypopituitarism | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | 18 Years | All | 22960 | N/A | United States | |
| 222 | NCT00184678 | February 2002 | 16 December 2017 | Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency | Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 18 Years | 25 Years | All | 161 | Phase 3 | Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom | |
| 223 | NCT00136032 | January 2002 | 19 February 2015 | Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women | Gender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Somatropin;Drug: Placebo | Massachusetts General Hospital | Not recruiting | 18 Years | 65 Years | Female | 63 | N/A | United States | |
| 224 | NCT00133354 | November 2001 | 19 February 2015 | Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys | Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency | Hypopituitarism | Drug: Arimidex (Anastrozole);Drug: Placebo;Drug: Growth Hormone | Nemours Children's Clinic | AstraZeneca;Genentech, Inc.;EMD Serono | Not recruiting | 11 Years | 18 Years | Male | 53 | Phase 2/Phase 3 | United States |
| 225 | NCT00027430 | September 2001 | 7 April 2015 | Androgen Replacement Therapy in Women With Hypopituitarism | TheraDerm Administration in Women With Hypopituitarism | Hypopituitarism | Drug: TheraDerm | Massachusetts General Hospital | Not recruiting | 18 Years | 50 Years | Female | 50 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | NCT00458991 | June 2001 | 16 December 2017 | rhGH Therapy on Hepatic Drug Metabolism | Recombinant Human Growth Hormone Therapy and Drug Metabolism | Growth Hormone Deficiency, Dwarfism | Drug: Dextromethorphan and Caffeine | University of Louisville | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 4 Years | 14 Years | All | 9 | N/A | United States |
| 227 | NCT01698944 | May 16, 2001 | 16 December 2017 | Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency | Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 12 Years | 25 Years | All | 7 | Phase 4 | Greece | |
| 228 | NCT01502124 | May 8, 2001 | 16 December 2017 | Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency | Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 3 Years | 17 Years | All | 78 | Phase 3 | United States | |
| 229 | NCT03018886 | May 2001 | 16 December 2017 | Diagnosing Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test | Growth Hormone Deficiency | Other: GHRH plus arginine test | Helsinki University Central Hospital | Not recruiting | 16 Years | 80 Years | All | 160 | N/A | Finland | |
| 230 | NCT00134420 | February 2001 | 15 August 2016 | Growth Hormone and Chromosome 18q- and Abnormal Growth | Growth Hormone Trial for Children With 18q- and Abnormal Growth | Loss of Chromosome 18q;Growth Hormone Deficiency | Drug: Nutropin AQ;Procedure: Arginine and Clonidine Stimulation Testing;Procedure: Growth Factors Laboratory Testing;Procedure: Neuropsychological Testing | The University of Texas Health Science Center at San Antonio | South Texas Veterans Health Care System;Genentech, Inc. | Not recruiting | N/A | 18 Years | Both | 20 | Phase 3 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT00572390 | January 2001 | 19 February 2015 | Oestrogen Withdrawal in Hypopituitary Women | Oestrogen Withdrawal in Hypopituitary Women | Hypopituitarism | Drug: oestrogen | University of Aarhus | Not recruiting | 18 Years | 60 Years | Female | 38 | N/A | Denmark | |
| 232 | NCT01543867 | January 2001 | 7 April 2015 | Safety and Efficacy of Long-term Somatropin Treatment in Children | Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA) | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Foetal Growth Problem;Small for Gestational Age;Genetic Disorder;Turner Syndrome;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | 18 Years | Both | 5442 | N/A | Germany | |
| 233 | NCT01563926 | October 23, 2000 | 16 December 2017 | Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency | An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner Syndrome | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | N/A | All | 168 | Phase 3 | Israel | |
| 234 | NCT00262249 | August 2000 | 16 December 2017 | Effect of Growth Hormone in Children With Growth Hormone Deficiency | Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature | Growth Hormone Disorder;Growth Hormone Deficiency in Children;Growth Disorder;Idiopathic Short Stature | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 3 Years | 15 Years | All | 173 | Phase 3 | United States | |
| 235 | NCT00931476 | April 6, 2000 | 16 December 2017 | A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin | A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24) | Growth Hormone Disorder;Adult Growth Hormone Deficiency;Healthy | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | Not recruiting | 20 Years | 50 Years | Male | 86 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT01088412 | April 1999 | 2 November 2015 | Observational Study of Somatropin Treatment in Children | The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) | Dwarfism, Growth Hormone Deficiency;Turner Syndrome;Infant, Small for Gestational Age;SHOX Protein, Human | Drug: Somatropin (rDNA origin) | Eli Lilly and Company | Not recruiting | N/A | N/A | Both | 22929 | N/A | ||
| 237 | NCT00490191 | January 1999 | 19 February 2015 | Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency | Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency | Hypopituitarism | Drug: Somatropin | Eli Lilly and Company | Not recruiting | 20 Years | N/A | Both | 387 | Phase 4 | United States;France;Germany;Italy;Puerto Rico;United Kingdom | |
| 238 | NCT01562834 | October 21, 1998 | 16 December 2017 | Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients | Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients | Growth Hormone Disorder;Adult Growth Hormone Deficiency | Drug: somatropin;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 50 Years | All | 22 | Phase 4 | France | |
| 239 | NCT00570011 | June 1997 | 19 February 2015 | Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients | Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients | Growth Hormone Deficiency | Drug: Somatropin | Eli Lilly and Company | University of Naples;University of Padua;University of Milan;University of Pisa | Not recruiting | 18 Years | N/A | Both | 112 | Phase 3 | United States |
| 240 | NCT00006394 | April 1997 | 19 February 2015 | Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency | Osteoporosis;Growth Hormone Deficiency | Drug: growth hormone | National Center for Research Resources (NCRR) | University of Pennsylvania | Not recruiting | 18 Years | N/A | Both | 72 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | NCT00174278 | February 1997 | 19 February 2015 | Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety. | Growth Hormone Deficiency;Growth Retardation | Drug: Somatropin | Pfizer | Not recruiting | 6 Years | N/A | Both | 14 | Phase 3 | France | |
| 242 | NCT00462475 | January 1996 | 19 February 2015 | Effect of 5 Years of GH Replacement on Atherosclerosis | Phase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary Patients | Hypopituitarism;Pituitary Tumors;Growth Hormone Deficiency | Drug: Recombinant Growth Hormone, Genotropin (Pfizer) | Federico II University | Not recruiting | 18 Years | 50 Years | Male | 20 | Phase 4 | Italy | |
| 243 | NCT00497484 | February 1995 | 19 February 2015 | Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia) | Evaluation of rhGH Replacement Therapy in Patients With Pseudohypoparathyroidism Type Ia (PHP Ia) | Pseudohypoparathyroidism;Growth Hormone Deficiency, Dwarfism | Drug: recombinant human somatotropin | University of Milan | Eli Lilly and Company | Not recruiting | 1 Year | 18 Years | Both | N/A | Italy | |
| 244 | NCT00227253 | September 1993 | 22 October 2019 | Chromosome 18 Clinical Research Center | The Chromosome 18 Clinical Research Center | Chromosome Aberrations;Growth Hormone Deficiency;Hypomyelination | Procedure: Determination of growth hormone status;Procedure: Measurement of growth, thyroid and sex hormone levels;Procedure: Behavior and neuropsychometric evaluations;Procedure: Audiological and ear, nose and throat examination;Procedure: Magnetic resonance imaging of the brain;Procedure: Dysmorphology evaluation;Procedure: Neurology examination;Procedure: Dental evaluation;Procedure: Speech pathology evaluation;Procedure: Psychiatric evaluation;Procedure: Orthopedic evaluation;Procedure: Ophthalmologic evaluation;Procedure: Gastrointestinal evaluation | The University of Texas Health Science Center at San Antonio | Recruiting | N/A | N/A | All | 1000 | Phase 3 | United States |