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 78. 下垂体前葉機能低下症 [臨床試験数:244,薬物数:222(DrugBank:44),標的遺伝子数:44,標的パスウェイ数:78] 

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.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
1NCT04121780October 8, 201928 October 2019Growth Hormone Replacement Therapy for Retried Professional Football PlayersInterventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone DeficiencyTBI (Traumatic Brain Injury);Concussion, Brain;Sport Injury;Anterior Pituitary Hyposecretion Syndrome;Hypopituitarism;Growth Hormone DeficiencyBiological: Growth Hormone;Other: PlaceboCenter for Neurological StudiesNovo Nordisk A/SRecruiting18 Years76 YearsMale42Phase 2United States
2NCT04020913July 22, 201922 October 2019Skeletal Muscle Effects of GH in BoysRecombinant 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 DeficiencyGrowth Hormone Deficiency;Idiopathic Short StatureDrug: Somatropin injectionNemours Children's ClinicNovo Nordisk A/SRecruiting6 Years11 YearsMale45N/AUnited States
3NCT03972345June 21, 201915 July 2019Influence 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 AgeDrug: Norditropin® FlexPro®Novo Nordisk A/SRecruitingN/A15 YearsAll750Phase 1Germany
4NCT03811535May 20, 201928 October 2019A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a DayA Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenDrug: Somapacitan;Drug: Norditropin®Novo Nordisk A/SRecruiting2 Years11 YearsAll192Phase 3United States;Algeria;Austria;Denmark;France;Germany;India;Israel;Italy;Japan;Korea, Republic of;Russian Federation;Slovenia;Switzerland;Ukraine;United Kingdom
5NCT03500913May 20194 March 2019Adipose Tissue and Serum Inflammation in GH DeficiencyAdipose Tissue and Serum Inflammation in Growth Hormone (GH) DeficiencyGrowth Hormone DeficiencyDrug: Growth HormoneColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 Years65 YearsAll60N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
6NCT03878992April 30, 20197 October 2019Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleEffects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal MuscleGrowth Hormone Deficiency;Growth Hormone TreatmentDrug: Genotropin miniquick 0.5 mg, injectionUniversity of AarhusAarhus University HospitalRecruiting18 Years100 YearsAll12N/ADenmark
7NCT03905850March 29, 201926 August 2019A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy SubjectsA 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 mLHealthy Volunteers;Growth Hormone DeficiencyDrug: somapacitanNovo Nordisk A/SNot recruiting18 Years45 YearsAll33Phase 1Germany
8NCT03775993March 1, 201925 February 2019Treatment of GHD Associated With CHFTreatment of Growth Hormone Deficiency Associated With Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled StudyHeart Failure;Growth Hormone DeficiencyDrug: Human growth hormone;Other: PlaceboFederico II UniversityNot recruiting18 Years85 YearsAll64Phase 3
9NCT03831880February 7, 20197 October 2019Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHDA 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 DEFICIENCYGrowth Hormone DeficiencyDrug: Genotropin;Drug: somatrogonPfizerRecruiting3 Years17 YearsAll90Phase 3United States;Czechia;United Kingdom
10EUCTR2018-001988-23-HU07/11/201812 November 2018A 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 GmbHAuthorisedFemale: yes
Male: yes
24Phase 2Serbia;Hungary;Poland;Ukraine;Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
11ChiCTR18000171442018-07-2516 July 2018A diverse response study of Pegylated Somatropin to treat growth hormone deficiency childrenA diverse response study of Pegylated Somatropin to treat growth hormone deficiency childrenGrowth hormone deficiencyTwo groups:low dose versus high dose of Pegylated Somatropin;The Children's Hospital, Zhejiang University School of MedicineRecruiting314BothTwo groups:900;Post-marketChina‘
12NCT03274973May 14, 201818 December 2018Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner SyndromeA 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 SyndromeGrowth DisordersDrug: ZomactonFerring PharmaceuticalsNot recruitingN/A18 YearsAll4Phase 2/Phase 3Germany
13NCT03226821February 7, 201811 June 2018Body Composition and Adipose Tissue in HIVBody Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin TherapyHIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body CompositionDrug: TesamorelinColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years68 YearsAll24Phase 4United States
14JPRN-JapicCTI-18396325/12/201716 July 2019Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA 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 DEFICIENCYTreatment 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 Recruiting311BOTH44Phase 3Japan
15NCT03344458December 19, 201721 January 2019A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical TrialenliGHten: 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 TrialGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma A/SRecruiting1 Year18 YearsAll300Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;New Zealand;Poland;Russian Federation;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
16NCT03874013December 7, 20173 June 2019Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: Genotropin;Drug: MOD-4023OPKO Health, Inc.Not recruiting3 Years11 YearsAll44Phase 3Japan
17NCT03305016November 13, 20173 June 2019A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone DeficiencyfliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHDGrowth Hormone Deficiency, Pediatric;Endocrine System Diseases;Hormone Deficiency;Pituitary DiseasesDrug: TransCon hGHAscendis Pharma A/SNot recruiting6 Months17 YearsAll146Phase 3United States;New Zealand;Canada;Australia
18NCT03053687November 1, 201711 June 2018Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of TherapyEffect 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 TrialIGHD - Isolated Growth Hormone Deficiency;Growth RetardationDietary Supplement: Nutritional supplementation standardized formula;Dietary Supplement: PlaceboRabin Medical CenterRecruiting3 Years14 YearsAll64N/AIsrael
19NCT03212131August 16, 20173 June 2019Investigation 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 FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNot recruiting18 Years75 YearsAll34Phase 1Slovakia
20NCT03225755August 1, 20174 March 2019Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH TherapyAdipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH TherapyGrowth Hormone DeficiencyDrug: Growth hormoneColumbia UniversityNovo Nordisk A/SRecruiting18 Years65 YearsAll12Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03186495June 20, 201718 June 2018Investigation 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 FunctionInvestigation 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 FunctionGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in ChildrenDrug: SomapacitanNovo Nordisk A/SNot recruiting18 Years75 YearsAll44Phase 1Germany
22EUCTR2016-003874-42-GB05/04/20173 July 2017An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA 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/AGrowth 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.AuthorisedFemale: yes
Male: yes
220Phase 3Serbia;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
23NCT03104010April 201716 December 2017A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHDA 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 DeficiencyDrug: Somatropin InjectionGeneScience 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 HospitalRecruiting18 Years60 YearsAll180Phase 2China
24NCT03145831March 31, 201711 June 2018A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone DeficiencyAn Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomavaratanVersartis Inc.Not recruiting3 YearsN/AAll21Phase 3United States;Japan
25NCT03075644March 3, 201728 October 2019A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: NorditropinNovo Nordisk A/SNot recruiting18 Years79 YearsAll62Phase 3Japan
No.TrialIDDate_
enrollement
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sponsor
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PhaseCountries
26NCT03290235March 1, 20178 January 2018Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenThe Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in ChildrenGrowth RetardationDrug: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Recruiting42 Months15 YearsAll1500Phase 4China
27JPRN-UMIN0000272602017/02/062 April 2019Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loadingChildren 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 30minutesOsaka City University Graduate School of Medicine2years-old15years-oldMale and Female15Not selectedJapan
28NCT02781727December 13, 201629 April 2019A 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 DiseasesDrug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of GenotropinAscendis Pharma A/SNot recruiting3 Years12 YearsAll161Phase 3United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine
29NCT02968004December 201615 July 2019Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenA 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 DeficiencyPediatric Growth Hormone DeficiencyDrug: MOD-4023;Drug: SomatropinOpko BiologicsNot recruiting3 Years11 YearsAll224Phase 3United 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
30NCT03309891December 201616 December 2017Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.Not recruiting3 Years11 YearsAll48Phase 2Ukraine
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
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PhaseCountries
31NCT02871986September 201629 August 2016Pubertal Induction in Individuals With HypogonadismVariability 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 InsufficiencyDrug: Routine transdermal oestrogen patchUniversity College, LondonNot recruiting10 Years30 YearsBoth24N/AUnited Kingdom
32NCT03015909August 11, 201614 January 2019Evaluation 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 DeviceShort Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner SyndromeDrug: SomatropinLG Life SciencesNot recruiting4 Years15 YearsAll116Phase 4Korea, Republic of
33NCT03203356May 30, 201616 December 2017Adrenal Function in GHD ChildrenEvaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH DeficiencyGrowth Hormone Treatment;Adrenal; Functional DisturbanceDrug: growth hormoneUniversity of PalermoNot recruiting5 Years12 YearsAll30N/AItaly
34NCT02782208May 201630 May 2016Lipolytic Effects of GH in Hypopituitary Patients in VivoLipolytic 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 DiseasesDrug: Acipimox;Drug: Placebo;Drug: GH substitution;Other: GH pauseUniversity of AarhusRecruiting18 Years70 YearsMale8N/ADenmark
35NCT02616562March 23, 201620 May 2019Investigating 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: Norditropin® FlexPro® penNovo Nordisk A/SNot recruiting30 Months10 YearsAll59Phase 2United States;Austria;Belgium;Brazil;France;Germany;India;Israel;Japan;Slovenia;Sweden;Turkey;Ukraine
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
36NCT02719990February 9, 201611 June 2018Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHDAn 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: somavaratanVersartis Inc.Premier Research Group plcNot recruiting18 Years75 YearsAll34Phase 2Australia;United States
37EUCTR2016-000446-56-Outside-EU/EEA11 April 2016Clinical 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. - CERESGrowth 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 AvailableFemale: yes
Male: yes
94Brazil
38EUCTR2016-003874-42-FR28 February 2019An efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiencyA 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/AGrowth 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
220Phase 3Serbia;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
39EUCTR2015-000531-32-AT10/12/20159 January 2017A 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 hormoneA 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 deficiencyGrowth 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/SAuthorisedFemale: yes
Male: yes
60Phase 2United States;Slovenia;Ukraine;Turkey;Austria;Israel;India;European Union;Brazil;Belgium;Germany;Japan;Sweden
40NCT02558829December 3, 201511 June 2018Validation of Macimorelin as a Test for Adult Growth Hormone DeficiencyConfirmatory 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 AnomaliesDrug: Macimorelin;Drug: InsulinAEterna ZentarisNot recruiting18 Years65 YearsAll157Phase 3United States;Austria;France;Germany;Italy;Poland;Serbia;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2015-002072-24-DE22/10/20158 January 2018A 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 RecruitingFemale: yes
Male: yes
40Phase 2United States;Australia;Germany;United Kingdom
42NCT02339090August 24, 201511 June 2018Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGHComparison 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 DisordersDrug: somavaratan;Drug: Daily rhGHVersartis Inc.Not recruiting3 Years11 YearsAll136Phase 3Belgium;Canada;Netherlands;Poland;Sweden;United States
43EUCTR2014-003796-32-DE21/08/20155 December 2016A 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 treatmentGrowth 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 RecruitingFemale: yes
Male: yes
150Phase 3Serbia;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
44EUCTR2014-002736-13-DE19/08/20155 December 2016A 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-deficiencyGrowth 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 RecruitingFemale: yes
Male: yes
140Phase 3United 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
45NCT02413138August 8, 201511 June 2018Versartis 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 DisordersDrug: Somavaratan (VRS-317)Versartis Inc.Not recruiting3 Years10 YearsAll41Phase 2/Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2015-001939-21-HU16/07/201513 February 2017A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A 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 deficiencyGrowth 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.AuthorisedFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of
47NCT02526420July 201521 November 2016Versartis International Trial in Adults With Long-Acting Growth HormoneAn Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)Adult Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.Premier Research Group plcNot recruiting23 Years70 YearsBoth36Phase 2United States;Australia;Germany;United Kingdom
48NCT02410356April 30, 201511 June 2018Study 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-DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: dGHTeva Pharmaceutical Industries, Ltd.Not recruiting18 YearsN/AAll34Phase 3United 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
49EUCTR2014-004525-41-SE10/04/201530 October 2017A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGHComparison 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. - VELOCITYGrowth 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 RecruitingFemale: yes
Male: yes
136Phase 3United States;Canada;Poland;Belgium;Netherlands;Sweden
50NCT02311894March 31, 201520 August 2018A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone DeficiencyA 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 DeficiencyDrug: SomatropinGenentech, Inc.Not recruiting3 Years14 YearsAll82Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2014-002698-13-SE03/02/201522 May 2017A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
52EUCTR2014-002698-13-SK14/01/20153 April 2017A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9A 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, IncNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden
53NCT02360046January 201522 October 2018The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic HypopituitarismThe 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 TrialHypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin SensitivityDrug: Hydrocortisone;Drug: PlaceboUniversity Hospital Inselspital, BerneNot recruiting18 YearsN/AAll30N/ASwitzerland
54NCT02418767January 201514 October 2019Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese VolunteersA 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 VolunteersGrowth Hormone DeficiencyDrug: MOD-4023;Drug: PlaceboOPKO Health, Inc.WCCT GlobalNot recruiting18 Years45 YearsMale42Phase 1United States
55NCT02946606January 201516 December 2017A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9A 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 DeficiencyDrug: GX-H9;Drug: GenotropinGenexine, Inc.Not recruiting20 Years65 YearsAll45Phase 2Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02976675January 201516 December 2017Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated 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 SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience 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 UniversityRecruiting3 Years18 YearsAll600Phase 4China
57NCT03249480January 201516 December 2017Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone DeficiencyPegylated 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 SomatropinGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience 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 HospitalRecruiting3 Years18 YearsAll900Phase 4China
58NCT02380235December 201416 December 2017Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)Growth Hormone DeficiencyBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Recruiting3 Years18 YearsAll600Phase 4China
59EUCTR2013-002892-16-GB20/11/201428 February 2019A 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 deficiencyA 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 1Growth 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/SNot Recruiting Female: yes
Male: yes
280Phase 3United States;Ukraine;Lithuania;Turkey;Russian Federation;United Kingdom;India;European Union;Brazil;Malaysia;Australia;South Africa;Latvia;Germany;Japan;Sweden
60EUCTR2014-000290-39-SE07/11/201411 April 2016A 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 deficiencyA 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 2Growth 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/SNot RecruitingFemale: yes
Male: yes
90European Union;Denmark;United Kingdom;Japan;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02314676November 201419 February 2015Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenDwarfism, PituitaryBiological: PEG-somatropinGeneScience Pharmaceuticals Co., Ltd.Recruiting3 YearsN/ABoth900Phase 4China
62NCT02908958November 201416 December 2017Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone DeficiencyClinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial IIGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience 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 HospitalRecruiting3 Years18 YearsAll900Phase 4China
63NCT02229851October 31, 201415 July 2019Trial 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 PeriodGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: somatropin;Drug: placeboNovo Nordisk A/SNot recruiting23 Years79 YearsAll301Phase 3United States;Australia;Brazil;Germany;India;Israel;Japan;Latvia;Lithuania;Malaysia;Norway;Poland;Romania;Russian Federation;South Africa;Sweden;Turkey;Ukraine;United Kingdom
64EUCTR2014-002039-32-DK02/09/201422 May 2017Fatigue 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 studySecondary 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 HospitalAuthorisedFemale: yes
Male: yes
Phase 4Denmark
65NCT02243852September 201419 February 2015Effects 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 DeficiencyDrug: Growth Hormone Replacement TherapyUniversity of LiverpoolPfizerRecruiting18 Years80 YearsBoth48N/AUnited Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
66NCT02018172July 201425 May 2015Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X DeviceGrowth Hormone Deficiency;Turner's SyndromeDrug: somatropinFerring PharmaceuticalsNot recruitingN/AN/ABoth3N/AFrance
67EUCTR2013-004468-69-HU11/06/201423 May 2016A 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 ChildrenGrowth 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 RecruitingFemale: yes
Male: yes
60Phase 2Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia
68NCT02092077April 30, 201411 June 2018A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient ChildrenA 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 ChildrenGrowth Hormone-DeficiencyDrug: TV-1106;Drug: somatropinTeva Pharmaceutical Industries, Ltd.Not recruiting3 Years11 YearsAll65Phase 2Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia
69NCT02068521March 3, 201411 June 2018Versartis Long-Term Safety Study of SomavaratanAn Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone DeficiencyPediatric Growth Hormone DeficiencyDrug: somavaratanVersartis Inc.Not recruiting3 YearsN/AAll385Phase 2/Phase 3United States
70NCT02507245January 20143 August 2015Observational 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 DeficiencyDrug: Growth Hormone-Releasing HormoneStefania La Grutta, MDNot recruiting5 Years15 YearsBoth48N/A
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
71NCT01973244December 16, 201311 June 2018A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somapacitan;Drug: somatropinNovo Nordisk A/SNot recruiting6 Years13 YearsAll32Phase 1Austria;Belgium;France;Israel;Macedonia, The Former Yugoslav Republic of;Norway;Slovenia;Spain;Sweden;Switzerland
72EUCTR2013-000013-20-SI09/12/201310 July 2015A 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 deficiencyA 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 deficiencyGrowth 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/SNot RecruitingFemale: yes
Male: yes
32European Union;Slovenia;Macedonia, the former Yugoslav Republic of;Spain;Belgium;Austria;Israel;Norway;Switzerland;Sweden
73EUCTR2013-000830-37-HU03/07/201326 November 2018Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone DeficiencyA 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 DeficiencyAdult 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 RecruitingFemale: yes
Male: yes
189Phase 3Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of
74NCT01947907July 201319 October 2017Safety, 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 HormoneAscendis Pharma A/SNot recruiting3 Years12 YearsAll53Phase 2Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine
75NCT01909479June 20133 September 2018A 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 DeficiencyA 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 DEFICIENCYAdult Growth Hormone DeficiencyDrug: MOD-4023;Other: PlaceboOpko BiologicsNot recruiting23 Years70 YearsAll189Phase 3Israel;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
76EUCTR2012-005066-36-NL15/05/201320 May 2013To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiencyEffect 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 factorsGrowth 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 CenterAuthorisedFemale: yes
Male: yes
Netherlands
77NCT01811576March 31, 201311 June 2018Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: TV-1106;Drug: Recombinant human growth hormoneTeva Pharmaceutical Industries, Ltd.Not recruiting23 Years65 YearsAll52Phase 2United States;Czechia;Germany;Greece;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic;Sweden
78EUCTR2012-004263-47-GB01/03/20133 November 2014Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-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 DeficiencyAdult 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 KGaAAuthorisedFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
79NCT01494779March 201319 February 2015Evaluation 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 RetardationDrug: SomatropinL.A.L Clinica Pesquisa e Desenvolvimento Ltda.Not recruiting18 Years32 YearsMale32Phase 1Brazil
80EUCTR2012-002787-27-HU11/02/201328 September 2015A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal childrenA 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/SNot RecruitingFemale: yes
Male: yes
52Phase 2Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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81NCT02500316February 201322 July 2019Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenSafety 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 ChildrenGrowth Hormone Deficiency (GHD)Drug: MOD-4023Opko BiologicsNot recruiting3 Years11 YearsAll48Phase 2United States;Belarus;Greece;Hungary;Russian Federation;Ukraine;Slovakia
82EUCTR2012-004975-37-HU21/01/201331 August 2015A 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 DeficiencyGrowth 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 RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden
83NCT01731028January 201319 February 2015Surveillance 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 PracticeGrowth Hormone DeficiencyDrug: SomatropinFerring PharmaceuticalsNot recruiting3 Years18 YearsBoth0N/A
84NCT01775358January 201319 February 2015Phase 1 Safety Study of ALRN-5281 in Healthy SubjectsA 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 VolunteersGrowth Hormone DeficiencyDrug: 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/kgAileron TherapeuticsNot recruiting20 Years50 YearsBoth33Phase 1United States
85NCT01901666January 201319 February 2015Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In RemissionASSESSMENT OF GH-IGF1 AXIS AND TO STUDY RESPONSE TO GH THERAPY IN CHILDREN WITH CML IN REMISSION HAVING GH DEFICIENCYChronic Myelogenous Leukemia;Short StatureDrug: Growth HormonePostgraduate Institute of Medical Education and ResearchRecruitingN/AN/ABoth20Phase 4India
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
86NCT01706783October 12, 201211 June 2018A 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 DeficiencyA 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 DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somapacitan;Drug: Norditropin NordiFlex®Novo Nordisk A/SNot recruiting20 Years70 YearsAll35Phase 1Denmark;Sweden
87NCT01718041October 201215 August 2016Versartis Trial in Children to Assess Long-Acting Growth HormoneA 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 MonthsPediatric Growth Hormone DeficiencyDrug: Experimental: VRS-317Versartis Inc.Not recruiting3 Years11 YearsBoth64Phase 1/Phase 2United States
88EUCTR2011-005377-23-ES18/07/201229 May 2017Study 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 CambraNot RecruitingFemale: yes
Male: yes
20Phase 2Spain
89NCT01209416June 201216 December 2017The Effect of Pharmacological Antilipolysis on the Metabolic Effects of GhrelinThe Effect of Pharmacological Antilipolysis on the Metabolic Effects of GhrelinMetabolism;Insulin Resistance;HypopituitarismDrug: Acipimox;Drug: Ghrelin;Other: PlaceboUniversity of AarhusNot recruiting18 Years65 YearsMale8N/ADenmark
90NCT01574859April 201219 February 2015Central Hypothyroidism and Cardiovascular RiskCentral Hypothyroidism and Cardiovascular Risk FactorsHypopituitarismOther: levothyroxineRigshospitalet, DenmarkNot recruitingN/AN/ABoth200N/ADenmark
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
91NCT01514500January 16, 201211 June 2018First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsFirst Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy SubjectsGrowth Hormone Disorder;Adult Growth Hormone Deficiency;Growth Hormone Deficiency in Children;HealthyDrug: somapacitan;Drug: placebo (somapacitan)Novo Nordisk A/SNot recruiting20 Years45 YearsMale105Phase 1Germany
92EUCTR2011-004553-60-HU10/01/20126 February 2017A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the bodySafety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient childrenPediatric 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.AuthorisedFemale: yes
Male: yes
56Phase 2Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation
93NCT01822340October 201114 March 2016Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency PatientsA 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 DeficiencyDrug: HM10560A;Drug: GenotropinHanmi Pharmaceutical Company LimitedNot recruiting23 Years60 YearsBoth72Phase 2Hungary;Romania
94NCT01440686September 201119 February 2015Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male VolunteersA 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 VolunteersGrowth Hormone DeficiencyDrug: Somatropin;Drug: PlaceboHanAll BioPharma Co., Ltd.Not recruiting19 Years50 YearsMale40Phase 1Korea, Republic of
95EUCTR2011-000460-10-GB03/08/20113 December 2012Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst 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 Studyidiopathic 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 SANot RecruitingFemale: yes
Male: yes
395Phase 4United Kingdom;Italy;Russian Federation;Spain;Canada;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT01467193August 201122 October 2018The 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 DeficiencyDietary Supplement: Fat diet;Other: 2h standardized aerobic exerciseUniversity Hospital Inselspital, BerneSwiss National Science FoundationNot recruiting18 Years80 YearsAll30Phase 3Switzerland
97EUCTR2011-001826-61-HU29/07/201131 August 2015A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiencyA 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 RecruitingFemale: yes
Male: yes
65Phase 2India;Korea, Republic of;Bulgaria;Russian Federation;Romania;Ukraine;Poland;Hungary;Serbia
98NCT01237041July 1, 201118 December 2018Free Fatty Acids, Body Weight, and Growth Hormones Secretion in ChildrenFree Fatty Acids, Body Weight, and Growth Hormone Secretion in ChildrenObesity;Short Stature;Growth Hormone DeficiencyDrug: 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 500mgEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting7 Years14 YearsAll37Phase 1/Phase 2United States
99EUCTR2009-017011-16-SE16/06/201118 September 2012Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind StudyTreatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind StudyLow 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 IINot RecruitingFemale: no
Male: no
Sweden
100EUCTR2010-020742-10-GB09/05/201119 March 2012Recombinant 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 PharmaNot RecruitingFemale: yes
Male: yes
63Phase 2Finland;United Kingdom;Spain;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
101NCT01327924April 201119 February 2015Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth HormoneEase of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily LifeGrowth 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 SystemsDrug: Norditropin NordiFlex®Novo Nordisk A/SNot recruitingN/A16 YearsBoth77N/AFrance
102NCT01359488March 201119 February 2015VRS-317 in Adult Subjects With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: VRS-317Versartis Inc.Not recruiting25 Years65 YearsBoth50Phase 1United States
103NCT01804413March 201119 February 2015Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone DeficiencyEffects of Pegvisomant-Priming With the Glucagon Stimulation Test in Assessing GH and Cortisol Reserve in Adults: a Randomized Proof-of-Concept Pilot StudyAdults Growth Hormone Deficiency.Drug: Pegvisomant;Drug: Regular insulinOregon Health and Science UniversityAarhus University HospitalRecruiting21 Years55 YearsBoth10N/AUnited States
104EUCTR2010-023430-23-HU17/01/201125 September 2012A 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 RecruitingFemale: yes
Male: yes
50Phase 3bHungary;United Kingdom;Czech Republic
105NCT01282164January 201116 December 2017The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic AxisThe Diagnostic Accuracy of the Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and the Hypothalamic-Pituitary-Adrenal AxisAdult Growth Hormone Deficiency;Hypothalamic-pituitary DisordersProcedure: Glucagon stimulation test and insulin tolerance test;Procedure: glucagon stimulation test and insulin tolerance testThe Cleveland ClinicMassachusetts General Hospital;Allegheny Endocrinology Associates;Oregon Health and Science UniversityNot recruiting18 Years80 YearsAll43N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
Inclusion_
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Inclusion_
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Target_
size
PhaseCountries
106NCT01243892November 201019 October 2017A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin DeviceA Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®Growth Hormone DeficiencyDevice: NuSpin;Drug: SomatropinGenentech, Inc.Not recruiting2 Years14 YearsAll18N/AUnited States
107NCT01247675November 201016 December 2017A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone DeficiencyA 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 DeficiencyAdult Growth Hormone DeficiencyDrug: ACP-001 (TransCon hGH);Drug: OmnitropeAscendis Pharma A/SNot recruiting20 Years70 YearsAll37Phase 2Denmark;Germany;Italy;Sweden
108EUCTR2009-017354-12-SE11/10/201031 July 2012A 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 PENA 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 PENSubjects 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, UKNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Czech Republic;Sweden
109NCT01090778October 201019 February 2015Diurnal 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 DeficiencyGrowth Hormone DeficiencyDrug: Norditropin SimpleXx (growth hormone)Aarhus University HospitalNovo Nordisk A/SNot recruiting18 Years75 YearsBoth8Phase 2Denmark
110NCT01237340October 201019 October 2017Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity StudyA 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 SeronoNot recruiting18 Years60 YearsAll59Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2010-021523-28-AT02/09/201019 November 2012A 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/SNot RecruitingFemale: yes
Male: yes
36Phase 2Denmark;Austria;Germany;Italy;Sweden
112NCT01225666August 201014 October 2019MOD-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 DeficiencyDrug: MOD-4023OPKO Health, Inc.Not recruiting23 Years60 YearsAll52Phase 2Czechia;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic
113EUCTR2010-019374-32-SK15/07/20107 August 2012A 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 RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
114EUCTR2010-019735-35-FR14/06/201019 March 2012Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânienEffets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânienDéficit 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 AmiensAuthorisedFemale: yes
Male: yes
France
115EUCTR2010-019296-30-GB18/05/201025 September 2012A 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 rhIGF1ALS (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 TrustNot RecruitingFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
116NCT01613573March 201019 February 2015Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenA Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD ChildrenGrowth Hormone DeficiencyDrug: somatropin AQ;Drug: pegylated somatropinGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and TechnologyNot recruiting4 Years10 YearsMale12Phase 1
117EUCTR2009-016783-37-SE07/01/201019 March 2012The 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-GHThe 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-GHGrowth hormone deficiency in adultsProduct 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 HospitalAuthorisedFemale: yes
Male: yes
60Sweden
118NCT00884000January 201019 February 2015A Study of Zomacton in Children With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: Genotropin;Drug: ZomactonFerring PharmaceuticalsNot recruiting3 Years11 YearsBoth165Phase 3Hungary;India;Israel;Poland;Romania;Russian Federation;Ukraine
119EUCTR2010-018781-23-NL2 October 2017Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation TestsDiagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation TestsTo 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 NutritionNot AvailableFemale: yes
Male: yes
Netherlands
120NCT01605331December 200919 February 2015Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)Growth Hormone DeficiencyDrug: sustained-release recombinant human GH (SR-rhGH)LG Life SciencesNot recruiting20 YearsN/ABoth132Phase 4
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
121NCT01007071November 1, 200916 December 2017Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone DeficiencyEffects of Growth Hormone on Cognition and Cerebral Metabolism in AdultsHypopituitarismDrug: Human Growth Hormone (1-134);Drug: PlaceboStanford UniversityGenentech, Inc.Not recruiting18 Years65 YearsAll11Phase 3United States
122NCT01062529October 200919 February 2015Peripheral Metabolic Effects of SomatostatinPeripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy ControlsAcromegaly;Growth Hormone Deficiency;DiabetesDrug: SomatostatinUniversity of AarhusThe Ministry of Science, Technology and Innovation, DenmarkNot recruiting18 Years50 YearsMale8N/ADenmark
123NCT01109017October 200919 February 2015Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone DeficiencyA Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHDGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruitingN/AN/ABoth387N/AJapan
124EUCTR2008-008240-25-FR02/09/200919 March 2012A 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 childrenA 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 childrengrowth 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/SAuthorisedFemale: yes
Male: yes
United Kingdom;Denmark;Slovenia;France;Spain
125EUCTR2009-010918-30-IE11/08/200919 March 2012Effect 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 HospitalAuthorisedFemale: yes
Male: yes
20Ireland
No.TrialIDDate_
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126NCT00934063July 200911 May 2015An 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 DeficiencyDrug: somatropin;Other: No treatment givenNovo Nordisk A/SNot recruiting18 YearsN/ABoth121N/AGermany
127EUCTR2008-001674-32-FI29/04/200916 October 2017NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOSNordiNet International Outcome Study (NordiNet IOS) - NordiNet IOSSmall 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 OyNot RecruitingFemale: yes
Male: yes
17000Phase 4Finland
128NCT00837863March 200919 February 2015Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: SomatropinAltus PharmaceuticalsRecruiting3 Years13 YearsBoth36Phase 2United States
129NCT01298180January 20098 June 2015Is 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 DeficiencyDrug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsyUniversity Hospital, ToulouseNot recruiting1 Year5 YearsBoth111Phase 4France
130NCT00851942September 200816 December 2017Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen TestDetermination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen TestHealthy;Adrenal Insufficiency;HypopituitarismDrug: Synacthen (Tetracosactrin)Cardiff UniversityNot recruiting18 Years80 YearsAll165Phase 4United Kingdom
No.TrialIDDate_
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131EUCTR2007-001746-40-HU25/08/200819 March 2012A 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., USANot RecruitingFemale: yes
Male: yes
45Phase 2bHungary
132NCT00675506July 200816 December 2017Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are ObesePhysiologic Effects of Long-Term GHRH1-44 in Abdominal ObesityAbdominal Obesity;Growth Hormone DeficiencyDrug: Growth hormone releasing hormone (GHRH) 1-44;Drug: PlaceboMassachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 Years55 YearsAll60Phase 2United States
133NCT01034735July 200819 February 2015r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence TrialPhase 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 VolunteersGrowth Failure;Growth Hormone DeficiencyBiological: r-hGH liquid (Saizen);Biological: r-hGH freeze-driedEMD SeronoNot recruiting18 Years45 YearsBoth30Phase 1Germany
134EUCTR2008-001061-29-DK17/06/200819 March 2012A 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/SNot RecruitingFemale: yes
Male: yes
32Denmark
135NCT00630487May 200819 October 2017Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone DeficiencyProspective, 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 DeficiencyDrug: Placebo;Drug: SomatropinPfizerNot recruiting18 Years65 YearsAll9Phase 3Germany
No.TrialIDDate_
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136EUCTR2007-000056-14-GB03/03/200819 March 2012Determination of method-specific normal cortisol and adrenal hormone responses to the short Synacthen test - Short Synacthen test StudyDetermination of method-specific normal cortisol and adrenal hormone responses to the short Synacthen test - Short Synacthen test StudyNormal, 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 UniversityAuthorisedFemale: yes
Male: yes
United Kingdom
137NCT00555009March 200819 October 2017Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain InjuryPlacebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.Brain Injuries;Growth Hormone DeficiencyDrug: Genotropin;Drug: PlaceboPfizerNot recruiting18 Years55 YearsAll10Phase 4France;Italy;Netherlands;Spain;Sweden;United Kingdom
138NCT00646815March 200819 February 2015Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyInsulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (genotropin)University of AarhusAarhus University HospitalNot recruiting18 Years60 YearsBoth24N/ADenmark
139NCT00666068February 200819 February 2015Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With HypopituitarismEffects of CRH on the Sleep in Patients With HypopituitarismHypopituitarismOther: corticotropin releasing hormone (CRH);Other: PlaceboMax-Planck-Institute of PsychiatryNot recruiting18 Years75 YearsBoth30N/AGermany
140EUCTR2007-005018-37-IE18/01/200819 March 2012Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacementOptimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement10 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 AghaAuthorisedFemale: no
Male: yes
20Ireland
No.TrialIDDate_
enrollement
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141EUCTR2007-000790-36-DE08/01/200829 May 2012Prospective, 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 StudyProspective, 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 StudyIsolated 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 GmbHNot RecruitingFemale: yes
Male: yes
50Germany
142NCT00684957January 200819 February 2015Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk FactorsDifferential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1Columbia UniversityTercicaNot recruiting25 Years65 YearsMale5N/AUnited States
143EUCTR2007-003586-41-NL17/12/200719 March 2012Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury - N/APlacebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury - N/AGrowth 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, UKNot RecruitingFemale: yes
Male: yes
120United Kingdom;Netherlands;France;Spain;Italy;Sweden
144NCT01365351December 1, 200716 December 2017Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTONNon-interventional Study With ZOMACTON in Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyOther: Growth hormoneFerring PharmaceuticalsFerring Arzneimittel GmbHNot recruitingN/AN/AAll1034N/AGermany
145NCT01306357September 200719 February 2015Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free DeviceEvaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale ProspectiveTurner's Syndrome;Human Growth Hormone DeficiencyDrug: SomatropinFerring PharmaceuticalsNot recruitingN/AN/ABoth87N/AFrance
No.TrialIDDate_
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146EUCTR2006-003678-82-NL10/07/200719 March 2012Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiencyPharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiencyClonidine 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 ResearchNot RecruitingFemale: yes
Male: yes
Netherlands
147NCT00324064July 200719 February 2015Sexually Dimorphic Effects of GHRH in Adult Growth Hormone TestingSexually Dimorphic Effects of GHRH in Adult Growth Hormone TestingGrowth Hormone DeficiencyProcedure: GHRH/arginine stimulation testingChildren's Mercy Hospital Kansas CityNot recruiting5 Years40 YearsBoth90N/AUnited States
148NCT00491582July 200719 February 2015The Effects of Growth Hormone (GH) on Lipid DepotsThe Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin ResistanceGrowth Hormone DeficiencyDrug: Growth hormone replacement therapy in growth hormone deficient patients only.University Hospital Inselspital, BerneSwiss National Science FoundationNot recruiting18 Years80 YearsBoth34N/ASwitzerland
149NCT00448747June 200716 December 2017Investigation 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 EfficacyDiagnosis of Adult Growth Hormone Deficiency (AGDH)Drug: AEZS-130 (formerly ARD-07);Drug: L-ARG+GHRHAEterna ZentarisNot recruiting18 YearsN/AAll100Phase 3United States
150NCT00615953May 200719 February 2015American Norditropin Studies - Registry of Growth Hormone (GH) PatientsAmerican Norditropin Studies: Web-Enabled Research (The ANSWER Program) ID#: HGH-2149Growth Hormone DeficiencyDrug: Norditropin Growth HormoneDuke UniversityNovo Nordisk A/SNot recruitingN/AN/ABoth79N/AUnited States
No.TrialIDDate_
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151NCT00432263April 20074 May 2015Treatment 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 InjuryBrain InjuriesDrug: Genotropin (PN-180,307) SomatropinPfizerNot recruiting18 Years55 YearsBoth0Phase 4
152NCT00455260April 200719 February 2015A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-DeficiencyA 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 DeficiencyGrowth Hormone DeficiencyDrug: hGH-ViaDerm™ System (hGH or somatropin);Device: hGH-ViaDerm™ SystemTeva Neuroscience, Inc.Teva Pharmaceutical Industries;TransPharma MedicalNot recruiting20 Years60 YearsBoth60Phase 1Israel;Ukraine
153NCT00601419March 200719 October 2017Drug Use Investigation of Somatropin for GHD-ADULTS.Drug Use Investigation of GENOTROPIN for GHD-ADULTS.Dwarfism, Growth Hormone DeficiencyDrug: SomatropinPfizerNot recruitingN/AN/AAll230N/A
154NCT01187550March 200719 October 2017Predictive 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, PituitaryDrug: Recombinant human growth hormone (r-hGH)Merck KGaAMerck Serono Co., Ltd., ChinaNot recruitingN/AN/AAll214Phase 4
155NCT01495468March 200716 December 2017Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency ChildrenPegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase ? Clinical TrialGrowth Hormone DeficiencyBiological: PEG-somatropinGeneScience 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 UniversityNot recruiting8 Years15 YearsAll343Phase 3China
No.TrialIDDate_
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156NCT00720902February 200719 February 2015Adult Growth Hormone Deficiency and Cardiovascular RiskAssessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary AdenomasGrowth Hormone DeficiencyProcedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsyColumbia UniversityNot recruiting19 Years65 YearsBoth8N/AUnited States
157EUCTR2006-005442-37-NL08/01/200719 March 2012PITUITARY 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 injuryPITUITARY 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 injuryisolated growth hormone deficiency after traumatic brain injuryTrade Name: recombinant growth hormone
Pharmaceutical Form: Solution for injection
University Medical Center St Radboud, department of neurologyAuthorisedFemale: yes
Male: yes
Netherlands
158NCT01576861January 200719 February 2015Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart FailureGrowth Hormone Deficiency;Chronic Heart FailureDrug: SomatotropinFederico II UniversityNot recruiting18 Years80 YearsBoth28Phase 2Italy
159EUCTR2006-001574-24-NL06/10/200619 March 2012Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiencyVisualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiencyPatients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteriesTrade 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 EndocrinologyAuthorisedFemale: yes
Male: yes
30Netherlands
160EUCTR2006-002278-24-DE06/10/200619 March 2012A 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 GmbHNot RecruitingFemale: yes
Male: yes
150Phase 3United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
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161EUCTR2005-004316-73-GB23/08/200618 April 2012The 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 & sensitivityThe 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 & sensitivityOsteoporosis 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 hospitalAuthorisedFemale: yes
Male: yes
100United Kingdom
162NCT00596037August 200619 February 2015Treatment of Adults With Growth Hormone DeficiencyA Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone DeficiencyPituitary Disorders;Adult Growth Hormone DeficiencyDrug: Growth hormone - LB03002LG Life SciencesBioPartners GmbHNot recruiting23 Years70 YearsBoth136Phase 3United States
163NCT00308464July 200619 February 2015A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone DeficiencyA Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient PatientsGrowth Hormone DeficiencyDrug: PHA-794428PfizerNot recruiting18 Years65 YearsBoth136Phase 2Belgium;Czech Republic;Denmark;France;Germany;Italy;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom
164EUCTR2005-005587-82-SE12/06/200619 March 2012A 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/AA 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/AAdult 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 LtdNot RecruitingFemale: yes
Male: yes
170Czech Republic;United Kingdom;Netherlands;Denmark;Italy;Greece;Poland;Sweden
165EUCTR2005-005593-79-GB02/06/200619 March 2012A 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/AA 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/APaediatric 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 LimitedNot RecruitingFemale: yes
Male: yes
32Germany;United Kingdom;Spain
No.TrialIDDate_
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PhaseCountries
166EUCTR2005-005613-38-IE31/05/200619 March 2012Assessment 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 ThompsonAuthorisedFemale: yes
Male: yes
50Ireland
167NCT01342146May 200616 December 2017Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency ChildrenEfficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 StudyGrowth Hormone DeficiencyDrug: pegylated Somatropin;Drug: Jintropin AQGeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and Technology;First Affiliated Hospital, Sun Yat-Sen University;Capital Medical University;Children's Hospital of Fudan UniversityNot recruitingN/AN/AAll101Phase 2
168NCT00294619April 200619 February 2015Treatment of Adults With Growth Hormone DeficiencyA 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 DeficiencyDrug: growth hormoneLG Life SciencesBioPartners GmbHNot recruiting23 Years70 YearsBoth147Phase 3United States
169NCT00314938April 200619 February 2015A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone DeficiencyA Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: PHA-794428PfizerNot recruiting6 Years12 YearsBoth32Phase 2Belgium;France;Germany;Israel;United Kingdom;Spain
170EUCTR2005-001315-22-AT09/03/200619 March 2012The 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 GesellschaftNot RecruitingFemale: yes
Male: yes
80Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
171EUCTR2005-004478-26-SE13/01/200628 August 2012Effects 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 universitetssjukhusetNot RecruitingFemale: yes
Male: yes
Sweden
172NCT00362063January 200616 December 2017304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone DeficiencyEffects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone (Nutropin)Baylor College of MedicineGenentech, Inc.Not recruiting1 Month17 YearsAll20N/AUnited States
173NCT00517062January 200619 February 2015Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production RatesEffects 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 AdultsGrowth Hormone DeficiencyDrug: Growth hormone (Genotropin);Drug: PlaceboOregon Health and Science UniversityNot recruiting18 Years75 YearsBoth16Phase 0United States
174EUCTR2005-000384-26-AT10/11/200529 April 2013A 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.BioPartnersNot RecruitingFemale: yes
Male: yes
138Phase 3Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden
175EUCTR2004-004292-11-SE06/10/200519 March 2012Discontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCODiscontinuation of long-term GH replacement therapy - a randomised, placebo controlled trial in adult GH deficiency. - DISCOThis 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 HospitalAuthorisedFemale: yes
Male: yes
60Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
176NCT00139945October 200519 February 2015Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient PatientsEffects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol InteractionHypopituitarismDrug: Human acylated ghrelinUniversity of AarhusNot recruiting18 Years60 YearsBoth8N/ADenmark
177NCT00552487October 200519 February 2015Isolated ACTH Deficiency in Patients With Hashimoto ThyroiditisIsolated ACTH Deficiency in Patients With Hashimoto ThyroiditisHashimoto Disease;Adrenal InsufficiencyDrug: synacthenUniversity of WuerzburgNot recruiting18 YearsN/ABoth62N/AGermany
178NCT00149708September 200519 February 2015Consequence of Lifetime Isolated Growth Hormone DeficiencyConsequence of Lifetime Isolated Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: growth hormone administration for 6 monthsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Genentech, Inc.Not recruiting18 Years80 YearsBoth400N/ABrazil
179NCT00271518September 200519 February 2015Treatment of Children With Insufficient Secretion of Growth HormoneA 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 HormoneGrowth Hormone Deficiency (GHD)Drug: growth hormone (somatropin)LG Life SciencesBioPartners GmbHNot recruiting3 Years11 YearsBoth144Phase 3United States
180NCT00397319August 200519 February 2015Growth Hormone's Effect on the Cardiovascular SystemThe Role of Growth Hormone in Cardiovascular HealthGrowth Hormone DeficiencyDrug: Growth HormoneVanderbilt UniversityPfizer;National Center for Research Resources (NCRR)Not recruiting18 Years65 YearsBoth26N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
181NCT00297713July 200519 February 2015Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug SafetyA 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 SafetyAdult Growth Hormone DeficiencyDrug: ALTU-238Altus PharmaceuticalsNot recruiting18 Years60 YearsBoth12Phase 2United States
182EUCTR2005-001658-25-BE16/06/20057 October 2014An 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 DeficiencyProduct 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 DevelopmentNot RecruitingFemale: no
Male: yes
8Belgium
183EUCTR2004-005184-15-GB24/05/200521 January 2013Central Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATSCentral Hypothyroidism and Adjusted Thyroxine dose Study (CHATS): impact of increasing free thyroxine levels in patients with hypopituitarism - CHATSCentral (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 TrustNot RecruitingFemale: yes
Male: yes
80United Kingdom
184NCT00187993May 200519 February 2015Growth Hormone Treatment of Young Growth Hormone-Deficient AdultsGrowth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.Growth Hormone DeficiencyDrug: Growth hormoneUniversity Hospital, AngersNovo Nordisk A/SRecruiting18 Years35 YearsBoth30N/AFrance
185NCT00256126May 200519 February 2015Predictive 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 DeficiencyDrug: SaizenMerck KGaANot recruiting2 Years16 YearsBoth318Phase 4Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
186NCT01351818May 200519 February 2015Adipocyte Function and Somtropin DeficiencyThe Fayds Project: Adipocyte Function and Somtropin DeficiencyGrowth Hormone DeficiencyDrug: Growth HormoneFerring PharmaceuticalsFerring SAUNot recruiting5 Years12 YearsBoth62N/ASpain
187NCT01604161May 20053 August 2015Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner SyndromeA 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 SyndromeDrug: somatropinNovo Nordisk A/SNot recruitingN/AN/ABoth2016N/AJapan
188EUCTR2004-004835-72-GB12/01/200530 June 2014A 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 lifeTrade 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 BirminghamUniversity Hospital Birmingham Foundation NHS TrustNot RecruitingFemale: yes
Male: yes
200United Kingdom
189NCT00109733January 200519 October 2017Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone DeficiencyA 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 DwarfismBiological: recombinant human growth hormoneEMD SeronoNot recruiting13 Years25 YearsAll31Phase 3United States
190NCT00163189January 200519 October 2017Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By GenotonormEvolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By GenotonormGrowth Hormone DeficiencyDrug: SomatropinPfizerNot recruitingN/AN/AAll98Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
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191NCT00212758January 200519 October 2017A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in BloodIGF-1 Generation Test in Children With Chronic Kidney DiseaseKidney Failure, Chronic;Growth Hormone DeficiencyDrug: Nutropin AQOregon Health and Science UniversityGenentech, Inc.Not recruiting2 Years18 YearsAll17Phase 4United States
192NCT00373386January 200519 February 2015Growth Hormone and Endothelial Function in ChildrenGrowth Hormone and Endothelial Function in ChildrenGrowth Hormone Deficiency;Panhypopituitarism;Short StatureDrug: growth hormoneOhio State UniversityNationwide Children's HospitalNot recruiting8 Years18 YearsBoth12Phase 4United States
193NCT00140413December 200419 October 2017Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve HypoplasiaEndocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve HypoplasiaGrowth Hormone Deficiency;Septo-Optic Dysplasia;HypopituitarismDrug: Nutropin AQChildren's Hospital Los AngelesGenentech, Inc.Not recruitingN/A5 YearsAll20Phase 4United States
194NCT00468624December 200419 February 2015Effect of Pegvisomant on GH/IGF-I Relationship in GHDA 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 DeficiencyDrug: 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 limbChristie Hospital NHS Foundation TrustNot recruiting18 Years70 YearsBothN/AUnited Kingdom
195NCT00591760December 200419 October 2017Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary TrialCorrection of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind StudyHeart Failure;Growth Hormone Deficiency;Ischemic Heart DiseaseDrug: SomatotropinFederico II UniversityNot recruiting18 Years80 YearsAll56Phase 2
No.TrialIDDate_
enrollement
Last_Refreshed_
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196EUCTR2004-002056-34-GB10/11/200421 August 2012Glucocorticosteroid replacement therapy and fibrinolysis in hypopituitarism - Glucocorticoid replacement therapy and fibrinolysisGlucocorticosteroid replacement therapy and fibrinolysis in hypopituitarism - Glucocorticoid replacement therapy and fibrinolysisHypopituitarismTrade 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 TrustAuthorisedFemale: yes
Male: yes
15United Kingdom
197NCT00184730November 200428 November 2016Long-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 DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting19 Years67 YearsBoth86Phase 3Japan
198EUCTR2004-002125-42-IT22/09/200419 March 2012EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESISEFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESISEVALUATION OF GROWTH HORMONE RELEASEPharmaceutical 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 TORINOAuthorisedFemale: yes
Male: yes
Italy
199NCT00459940September 200419 February 2015The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD PatientsCan Growth Hormone's Lipolytic and Insulin-Antagonistic Effects be Modified by Peroxisome Proliferator-Activated Gamma Agonists?Growth Hormone DeficiencyDrug: PioglitazoneUniversity of AarhusNot recruiting19 Years71 YearsMale20N/ADenmark
200NCT00182091August 200419 October 2017Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone DeficiencyEffects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of AcromegalyAcromegaly;Growth Hormone Deficiency;Pituitary DiseaseDrug: Recombinant human growth hormone;Drug: SalineMassachusetts General HospitalNot recruiting18 Years85 YearsAll75N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
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201NCT00489294August 200419 February 2015Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone DeficiencyAn Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy VolunteersGrowth Hormone DeficiencyDrug: SyntropinPhage Pharmaceuticals, Inc.Not recruiting18 Years45 YearsBoth20Phase 1United States
202NCT00497562May 200419 February 2015Growth 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 FibromialgiaFibromyalgia;Growth Hormone DeficiencyDrug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group);Drug: amitriptyline, fluoxetine and tramadol alone (control group)Centro Medico TeknonNot recruiting18 YearsN/ABothPhase 2Spain
203NCT00080483March 200419 October 2017Testosterone and Growth Hormone for Bone Loss in MenWill Testosterone and Growth Hormone Improve Bone Structure?Hypopituitarism;Hypogonadism;Growth Hormone DeficiencyDrug: Testosterone plus somatropin;Drug: testosteroneUniversity of PennsylvaniaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AMale35Phase 2United States
204NCT00191165March 200419 October 2017Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone DeficiencyEfficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyNot recruitingN/A14 YearsAll27Phase 3Italy
205NCT00360074February 200419 February 2015Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine SupplementationA Randomised, Controlled, Crossover Study: Treatment With Thyroxin Compared to Thyroxin + Triiodothyronin in Patients With Secondary HypothyroidismSecondary Hypothyroidism;Hypopituitarism;HyperlipidemiasDrug: Thyroxin, TriiodothyronineUniversity Hospital FreiburgNot recruiting18 Years75 YearsBoth25Phase 4Germany
No.TrialIDDate_
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206NCT00184743December 6, 200316 December 2017Long-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 DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting18 Years65 YearsAll112Phase 3Japan
207NCT00929799November 200319 February 2015Growth Hormone and Glucose MetabolismEffects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: recombinant human Growth Hormone (Genotropin® )Charite University, Berlin, GermanyNot recruiting18 YearsN/ABoth6Phase 4Germany
208NCT00957671November 200311 June 2018Anterior Pituitary Hormone Replacement in Traumatic Brain InjuryAnterior Pituitary Hormone Replacement in Traumatic Brain InjuryGrowth Hormone Deficiency;Traumatic Brain InjuryDrug: Recombinant human growth hormoneThe University of Texas Medical Branch, GalvestonThe Moody FoundationNot recruiting21 YearsN/AAll15Phase 4United States
209NCT02693522October 200314 March 2016Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone DeficiencyPhase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: somatropin;Drug: EutropinDaewoong Pharmaceutical Co. LTD.Not recruiting18 YearsN/ABoth52Phase 3Korea, Republic of
210NCT01157793September 200319 February 2015A 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 AdulthoodA 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 AdulthoodDwarfism;Growth Hormone DeficiencyDrug: r-hGHMerck KGaANot recruiting14 Years25 YearsBoth34Phase 4
No.TrialIDDate_
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PhaseCountries
211NCT00144391July 200316 December 2017Testosterone Gel Applied to Women With Pituitary Gland ProblemsPhysiologic Testosterone Replacement in Women With HypopituitarismPanhypopituitarismDrug: Transdermal Testosterone gelCharles Drew University of Medicine and ScienceEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting18 Years55 YearsFemale20Phase 4United States
212NCT01543880July 200311 May 2015Safety and Efficacy of Long-term Somatropin Treatment in AdultsNon-interventional Study of Safety and Efficacy of Long-term Somatropin Treatment in AdultsGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting20 YearsN/ABoth752N/AGermany
213NCT01580605July 200319 February 2015French National Registry of Adults With Growth Hormone Deficiency Treated With SomatropinProspective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was StartedGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruitingN/AN/ABoth331N/AFrance
214NCT00476385June 200319 February 2015Practicability and Acceptability of Stylomax® in ChildrenUsability and Acceptability of Stylomax® in Growth Hormone Deficient Children.Growth Hormone DeficiencyDrug: somatropineSanofiNot recruiting3 Years18 YearsBoth12Phase 3France
215NCT00600808June 200319 February 2015Sustained Release Formulation of Somatropin (rDNA Origin)for InjectionA 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 DeficiencyDrug: BPLG-003BioPartners GmbHLG Life SciencesNot recruiting4 Years10 YearsBoth51Phase 2/Phase 3
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216NCT00519558May 31, 200316 December 2017Growth Hormone Deficiency in Adults (GHDA)Investigation of the Efficacy and Safety of NN-220 for 24 Weeks in Adults With Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting18 Years65 YearsAll121Phase 3Japan
217NCT00567385March 10, 200316 December 2017Liquid Somatropin Formulation in Children With Growth Hormone DeficiencyAn Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNot recruiting3 Years18 YearsAll176Phase 4Turkey
218NCT00191360January 200319 February 2015Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone DeficiencyExtended Clinical Study of LY137998 [Somatropin (Recombinant DNA Origin)] in Adults With Growth Hormone DeficiencyAdult Growth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyNot recruiting18 Years65 YearsBoth68Phase 3Japan
219NCT00638053November 200219 February 2015A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head InjuryHead 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 InjuryBrain Injuries;Growth Hormone Deficiency DwarfismGenetic: somatropinPfizerNot recruiting18 YearsN/ABoth100Phase 4United States
220NCT01088399September 200219 October 2017A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient AdultsThe Global Hypopituitary Control and Complications StudyHypopituitarism;Pituitary Insufficiency;Growth Hormone Deficiency, AdultDrug: Somatropin (rDNA origin)Eli Lilly and CompanyNot recruiting18 YearsN/AAll10673N/A
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221NCT01009905June 24, 200216 December 2017An 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 HormoneGrowth Hormone Disorder;Pituitary Dwarfism;HypopituitarismDrug: somatropinNovo Nordisk A/SNot recruitingN/A18 YearsAll22960N/AUnited States
222NCT00184678February 200216 December 2017Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone DeficiencyEffect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting18 Years25 YearsAll161Phase 3Australia;Austria;Belgium;France;Germany;Hungary;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom
223NCT00136032January 200219 February 2015Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient WomenGender-Specific Effects of Physiologic GH Administration on Cardiovascular Risk Factors in Women With Growth Hormone DeficiencyGrowth Hormone DeficiencyDrug: Somatropin;Drug: PlaceboMassachusetts General HospitalNot recruiting18 Years65 YearsFemale63N/AUnited States
224NCT00133354November 200119 February 2015Arimidex Multicenter Trial in Growth Hormone (GH) Deficient BoysDouble-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) DeficiencyHypopituitarismDrug: Arimidex (Anastrozole);Drug: Placebo;Drug: Growth HormoneNemours Children's ClinicAstraZeneca;Genentech, Inc.;EMD SeronoNot recruiting11 Years18 YearsMale53Phase 2/Phase 3United States
225NCT00027430September 20017 April 2015Androgen Replacement Therapy in Women With HypopituitarismTheraDerm Administration in Women With HypopituitarismHypopituitarismDrug: TheraDermMassachusetts General HospitalNot recruiting18 Years50 YearsFemale50N/AUnited States
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226NCT00458991June 200116 December 2017rhGH Therapy on Hepatic Drug MetabolismRecombinant Human Growth Hormone Therapy and Drug MetabolismGrowth Hormone Deficiency, DwarfismDrug: Dextromethorphan and CaffeineUniversity of LouisvilleEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting4 Years14 YearsAll9N/AUnited States
227NCT01698944May 16, 200116 December 2017Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone DeficiencyCardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone DeficiencyGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropinNovo Nordisk A/SNot recruiting12 Years25 YearsAll7Phase 4Greece
228NCT01502124May 8, 200116 December 2017Safety and Efficacy of Somatropin in Children With Growth Hormone DeficiencyNorditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in ChildrenDrug: somatropinNovo Nordisk A/SNot recruiting3 Years17 YearsAll78Phase 3United States
229NCT03018886May 200116 December 2017Diagnosing Adult Growth Hormone DeficiencyDiagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation TestGrowth Hormone DeficiencyOther: GHRH plus arginine testHelsinki University Central HospitalNot recruiting16 Years80 YearsAll160N/AFinland
230NCT00134420February 200115 August 2016Growth Hormone and Chromosome 18q- and Abnormal GrowthGrowth Hormone Trial for Children With 18q- and Abnormal GrowthLoss of Chromosome 18q;Growth Hormone DeficiencyDrug: Nutropin AQ;Procedure: Arginine and Clonidine Stimulation Testing;Procedure: Growth Factors Laboratory Testing;Procedure: Neuropsychological TestingThe University of Texas Health Science Center at San AntonioSouth Texas Veterans Health Care System;Genentech, Inc.Not recruitingN/A18 YearsBoth20Phase 3United States
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231NCT00572390January 200119 February 2015Oestrogen Withdrawal in Hypopituitary WomenOestrogen Withdrawal in Hypopituitary WomenHypopituitarismDrug: oestrogenUniversity of AarhusNot recruiting18 Years60 YearsFemale38N/ADenmark
232NCT01543867January 20017 April 2015Safety and Efficacy of Long-term Somatropin Treatment in ChildrenNon-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 StatureDrug: somatropinNovo Nordisk A/SNot recruitingN/A18 YearsBoth5442N/AGermany
233NCT01563926October 23, 200016 December 2017Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone DeficiencyAn Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH DeficiencyGrowth Hormone Disorder;Growth Hormone Deficiency in Children;Genetic Disorder;Turner SyndromeDrug: somatropinNovo Nordisk A/SNot recruitingN/AN/AAll168Phase 3Israel
234NCT00262249August 200016 December 2017Effect of Growth Hormone in Children With Growth Hormone DeficiencyEffect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short StatureGrowth Hormone Disorder;Growth Hormone Deficiency in Children;Growth Disorder;Idiopathic Short StatureDrug: somatropinNovo Nordisk A/SNot recruiting3 Years15 YearsAll173Phase 3United States
235NCT00931476April 6, 200016 December 2017A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of SomatropinA 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;HealthyDrug: somatropin;Drug: placeboNovo Nordisk A/SNot recruiting20 Years50 YearsMale86Phase 1United States
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236NCT01088412April 19992 November 2015Observational Study of Somatropin Treatment in ChildrenThe Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)Dwarfism, Growth Hormone Deficiency;Turner Syndrome;Infant, Small for Gestational Age;SHOX Protein, HumanDrug: Somatropin (rDNA origin)Eli Lilly and CompanyNot recruitingN/AN/ABoth22929N/A
237NCT00490191January 199919 February 2015Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone DeficiencyComparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone DeficiencyHypopituitarismDrug: SomatropinEli Lilly and CompanyNot recruiting20 YearsN/ABoth387Phase 4United States;France;Germany;Italy;Puerto Rico;United Kingdom
238NCT01562834October 21, 199816 December 2017Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult PatientsRandomized 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 PatientsGrowth Hormone Disorder;Adult Growth Hormone DeficiencyDrug: somatropin;Drug: placeboNovo Nordisk A/SNot recruiting18 Years50 YearsAll22Phase 4France
239NCT00570011June 199719 February 2015Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult PatientsEfficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult PatientsGrowth Hormone DeficiencyDrug: SomatropinEli Lilly and CompanyUniversity of Naples;University of Padua;University of Milan;University of PisaNot recruiting18 YearsN/ABoth112Phase 3United States
240NCT00006394April 199719 February 2015Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone DeficiencyOsteoporosis;Growth Hormone DeficiencyDrug: growth hormoneNational Center for Research Resources (NCRR)University of PennsylvaniaNot recruiting18 YearsN/ABoth72N/AUnited States
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241NCT00174278February 199719 February 2015Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature SecondaryTreatment 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 RetardationDrug: SomatropinPfizerNot recruiting6 YearsN/ABoth14Phase 3France
242NCT00462475January 199619 February 2015Effect of 5 Years of GH Replacement on AtherosclerosisPhase 4 Study of Recombinant GH on Intima-Media Thickness at Common Carotids and on Cardiovascular Risk Factors in Hypopituitary PatientsHypopituitarism;Pituitary Tumors;Growth Hormone DeficiencyDrug: Recombinant Growth Hormone, Genotropin (Pfizer)Federico II UniversityNot recruiting18 Years50 YearsMale20Phase 4Italy
243NCT00497484February 199519 February 2015Evaluation 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, DwarfismDrug: recombinant human somatotropinUniversity of MilanEli Lilly and CompanyNot recruiting1 Year18 YearsBothN/AItaly
244NCT00227253September 199322 October 2019Chromosome 18 Clinical Research CenterThe Chromosome 18 Clinical Research CenterChromosome Aberrations;Growth Hormone Deficiency;HypomyelinationProcedure: 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 evaluationThe University of Texas Health Science Center at San AntonioRecruitingN/AN/AAll1000Phase 3United States

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