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Leuprolide    (DrugBank: Leuprolide)

5 diseases
告示番号疾患名（ページ内リンク）臨床試験数
1球脊髄性筋萎縮症1
2筋萎縮性側索硬化症1
3脊髄性筋萎縮症1
51全身性強皮症1
76下垂体性ゴナドトロピン分泌亢進症11

1. 球脊髄性筋萎縮症　［臨床試験数：17，薬物数：16（DrugBank：8），標的遺伝子数：10，標的パスウェイ数：15］
Searched query = "Spinal and bulbar muscular atrophy", "Spinobulbar muscular atrophy", "SBMA", "Kennedy disease", "Kennedy-Alter-Sung syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 17 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT00004771
(ClinicalTrials.gov)		October 199224/2/2000Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityCompleted18 YearsN/AMale40Phase 2NULL

2. 筋萎縮性側索硬化症　［臨床試験数：508，薬物数：530（DrugBank：146），標的遺伝子数：170，標的パスウェイ数：221］
Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 508 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT00004771
(ClinicalTrials.gov)		October 199224/2/2000Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityCompleted18 YearsN/AMale40Phase 2NULL

3. 脊髄性筋萎縮症　［臨床試験数：179，薬物数：102（DrugBank：26），標的遺伝子数：52，標的パスウェイ数：78］
Searched query = "Spinal muscular atrophy", "Myelopathic muscular atrophy", "SMA I", "Werdnig-Hoffman disease", "SMA II", "Dubowitz disease", "SMA III", "Kugelberg-Welander disease", "SMA IV"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 179 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT00004771
(ClinicalTrials.gov)		October 199224/2/2000Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityCompleted18 YearsN/AMale40Phase 2NULL

51. 全身性強皮症　［臨床試験数：466，薬物数：536（DrugBank：142），標的遺伝子数：110，標的パスウェイ数：210］
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 466 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT01257802
(ClinicalTrials.gov)		May 20119/12/2010GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesGnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesLupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial DiffuseDrug: depot leuprolide acetate 3.75 mg;Drug: PlaceboJoseph MccuneNational Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Terminated18 Years40 YearsFemale14Phase 3United States

76. 下垂体性ゴナドトロピン分泌亢進症　［臨床試験数：25，薬物数：41（DrugBank：11），標的遺伝子数：3，標的パスウェイ数：10］
Searched query = "Pituitary gonadotropin secretion hyperthyroidism", "Gonadotropin secreting pituitary adenoma", "Central precocious puberty", "Gonadotropin producing pituitary adenoma"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
11 / 25 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03695237
(ClinicalTrials.gov)		October 24, 20182/10/2018A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)Central Precocious Puberty (CPP)Drug: Leuprolide Acetate (LA)AbbVieNULLActive, not recruiting2 Years11 YearsAll45Phase 3United States;Puerto Rico
2NCT02974270
(ClinicalTrials.gov)		June 201619/5/2016Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide AcetateAnalysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide AcetatePrecocious Puberty, CentralDrug: LeuprolideKyungpook National UniversityNULLRecruitingN/A9 YearsBoth100Phase 4Korea, Republic of
3NCT02811471
(ClinicalTrials.gov)		June 201621/6/2016Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious PubertyAn Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty—Part A and BCentral Precocious PubertyDrug: LeuprolideNemours Children's ClinicTolmar Inc.Recruiting2 Years9 YearsBoth5Phase 3United States
4NCT02452931
(ClinicalTrials.gov)		August 31, 20155/5/2015Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious PubertyAn Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious PubertyPrecocious Puberty, CentralDrug: Leuprolide Acetate 45 mgTolmar Inc.NULLCompleted2 Years9 YearsAll64Phase 3United States;Argentina;Canada;Chile;Mexico;New Zealand
5NCT01634321
(ClinicalTrials.gov)		July 20113/7/2012The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious PubertyThe Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective StudyCentral Precocious PubertyDrug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)Daewoong Pharmaceutical Co. LTD.NULLCompleted4 Years9 YearsBoth63Phase 4Korea, Republic of
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT00667446
(ClinicalTrials.gov)		December 200824/4/2008Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious PubertyA 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious PubertyPrecocious;Leuprolide Acetate;Luteinizing Hormone (LH);Gonadotrophin-releasing Hormone Agonist (GnRHa);Tanner Staging;Depot Formulation;Suppression of LH;Central Precocious Puberty (CPP);Gonadotrophin-releasing Hormone (GnRH);Lupron;GnRH Analog;Pediatrics Central Precocious PubertyDrug: Leuprolide Acetate 3 Month DepotAbbVie (prior sponsor, Abbott)NULLCompletedN/AN/AAll72Phase 3United States;Puerto Rico
7NCT00635817
(ClinicalTrials.gov)		June 20087/3/2008A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious PubertyA Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious PubertyPuberty, PrecociousDrug: Leuprolide acetate 11.25 mg;Drug: Leuprolide acetate 30 mgAbbottNULLCompleted2 Years11 YearsAll84Phase 3United States;Puerto Rico
8NCT00438217
(ClinicalTrials.gov)		May 200621/2/2007Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty ChildrenAnalysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty ChildrenCentral Precocious PubertyDrug: Triptorelin (GnRH agonists);Drug: Leuprolide (GnRH agonists)University of PisaNULLRecruiting1 Year18 YearsBoth100Phase 4Italy
9NCT00660010
(ClinicalTrials.gov)		January 199115/4/2008Study of Lupron Depot In The Treatment of Central Precocious PubertyStudy of Lupron Depot In The Treatment of Central Precocious PubertyPuberty, PrecociousDrug: Lupron (leuprolide acetate)AbbottNULLCompletedN/A10 YearsAll55Phase 3United States
10EUCTR2014-004493-42-Outside-EU/EEA
(EUCTR)		03/12/2014A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature pubertyA Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate theEfficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulationsin Children with Central Precocious Puberty Central Precocious Puberty
MedDRA version: 17.1;Level: LLT;Classification code 10073186;Term: Central precocious puberty;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]		Trade Name: trade name depends on the source of the product
Product Name: Leuprolide acetate depot
INN or Proposed INN: LEUPRORELIN ACETATE
Trade Name: trade name depends on the source of the product
INN or Proposed INN: LEUPRORELIN ACETATE		Abbvie previously known as AbbottNULLNAFemale: yes
Male: yes		80Phase 3United States;Puerto Rico
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11EUCTR2014-004494-16-Outside-EU/EEA
(EUCTR)		03/12/2014A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature pubertyA 36 Month, Multi-Center, Open-Label Extension Study to Evaluate theSafety of Leuprolide Acetate 11.25 mg and 30 mg Formulations inChildren with Central Precocious Puberty Central Precocious Puberty
MedDRA version: 17.1;Level: LLT;Classification code 10073186;Term: Central precocious puberty;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]		Trade Name: trade name depends on the source of the product
INN or Proposed INN: LEUPRORELIN ACETATE
Trade Name: trade name depends on the source of the product’
INN or Proposed INN: LEUPRORELIN ACETATE		Abbvie previously known as AbbottNULLNAFemale: yes
Male: yes		72United States;Puerto Rico

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