Leuprolide ( DrugBank: Leuprolide )


5 diseases
IDDisease name (Link within this page)Number of trials
1Spinal and bulbar muscular atrophy1
2Amyotrophic lateral sclerosis1
3Spinal muscular atrophy1
51Scleroderma1
76Pituitary gonadotropin secretion hyperthyroidism12

1. Spinal and bulbar muscular atrophy


Clinical trials : 18 Drugs : 15 - (DrugBank : 8) / Drug target genes : 10 - Drug target pathways : 17
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. Amyotrophic lateral sclerosis


Clinical trials : 645 Drugs : 589 - (DrugBank : 163) / Drug target genes : 150 - Drug target pathways : 225
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. Spinal muscular atrophy


Clinical trials : 237 Drugs : 123 - (DrugBank : 29) / Drug target genes : 51 - Drug target pathways : 75
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. Scleroderma


Clinical trials : 525 Drugs : 565 - (DrugBank : 148) / Drug target genes : 114 - Drug target pathways : 217
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. Pituitary gonadotropin secretion hyperthyroidism


Clinical trials : 29 Drugs : 44 - (DrugBank : 14) / Drug target genes : 5 - Drug target pathways : 15
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05341115
(ClinicalTrials.gov)
March 20, 202318/4/2022A Study of Leuprolide Acetate Depot in Children With Central Precocious PubertyAn Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)Central Precocious PubertyDrug: Leuprorelin Acetate Depot 3MTakedaNULLNot yet recruitingN/A9 YearsAll80Phase 4China
2NCT03695237
(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
3NCT02974270
(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
4NCT02811471
(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
5NCT02452931
(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
6NCT01634321
(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
7NCT00667446
(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
8NCT00635817
(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
9NCT00438217
(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
10NCT00660010
(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
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
12EUCTR2014-004493-42-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