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12

1. 球脊髄性筋萎縮症


臨床試験数 : 18 薬物数 : 15 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 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. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 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. 脊髄性筋萎縮症


臨床試験数 : 237 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 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. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 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. 下垂体性ゴナドトロピン分泌亢進症


臨床試験数 : 29 薬物数 : 44 - (DrugBank : 14) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 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
11EUCTR2014-004493-42-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
12EUCTR2014-004494-16-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