Leuprorelin ( DrugBank: Leuprorelin )


3 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7
67多発性嚢胞腎2
76下垂体性ゴナドトロピン分泌亢進症9

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
1NCT03555578
(ClinicalTrials.gov)
November 2, 20171/6/2018Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)Spinal and Bulbar Muscular AtrophyDrug: Leuprorelin AcetateTakedaNULLRecruitingN/AN/AAll300Japan
2JPRN-JapicCTI-183981
02/11/201701/06/2018Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA)Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA) Spinal and bulbar muscular atrophyIntervention name : Leuprorelin Acetate
Dosage And administration of the intervention : Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLrecruitingBOTH300NANULL
3JPRN-JMA-IIA00080
02/201226/01/2012Phase 2 Clinical Trial of Leuprorelin acetate in patients with SBMA (JASMITT-2)Double-blind Placebo-controlled Phase 2 Clinical Trial of TAP-144-SR (3M) in patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar muscular atrophyIntervention type:DRUG. Intervention1:TAP-144-SR(3M) , Dose form:INJECTION, Route of administration:SUBCUTANEOUS. Control intervention1:placebo, Dose form:INJECTION, Route of administration:SUBCUTANEOUS.JASMITT Clinical Trial OfficeJichi med college, Chiba univ., Univ of Tokyo, Tokyo med & dental univ.Completed>=30 YEARS<70 YEARSMale100Phase 2Japan
4JPRN-UMIN000001455
2008/10/0123/10/2008Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS)Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS) - Open clinical trial of Leuprorelin Acetate (SR) in patients with KAS Kennedy-Alter-Sung syndrome (KAS)Leuprorelin acetate (SR) 11.25mg subcutaneous infection per 12 weeksDepartment of NeurologyChiba University Graduate School of MedicineNULL20years-oldNot applicableMale10Not selectedJapan
5JPRN-JMA-IIA00111
29/08/200722/02/2013Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar Muscular Atrophy (SBMA)Intervention type:DRUG. Intervention1:TAP-144-SR(3M), Dose form:INJECTION, Route of administration:SUBCUTANEOUS, intended dose regimen:every 12 week. Control intervention1:N.A., Dose form:NOT APPLICABLE, Route of administration:NOT APPLICABLE , Intended dose regimen:N.A..Gen SobueIchiro Yabe, Masashi Aoki, Imaharu Nakano, Kazuaki Kanai, Hidehiro Mizusawa, Tomotaka Yamamoto, Kazuko Hasegawa, Masatoyo Nishizawa, Hiroaki Miyajima, Norio Kanda, Kenji Nakajima, Akira Tsujino, Makoto UchinoCompleted>=30 YEARS<71 YEARSMale152Phase 3Japan
6JPRN-JMA-IIA00009
13/09/200624/08/2006Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar Muscular Atrophy (SBMA)Intervention type:DRUG. Intervention1:TAP-144-SR(3M), Dose form:INJECTION, Route of administration:SUBCUTANEOUS. Control intervention1:placebo, Dose form:INJECTION, Route of administration:SUBCUTANEOUS.JASMITT Clinical Trial OfficeHokkaido University, Tohoku University, Jichi Medical College, Chiba University, University of Tokyo, Tokyo Medical and Dental University, NHO Sagamitara hospital, Niigata University, Hamamatsu Medical college, Kobe University, Tottori University, Nagasaki University, Kumamoto UniversityCompleted>=30 YEARS<70 YEARSMale170Phase 3Japan
7JPRN-UMIN000000474
2003/09/0101/09/2006Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) - Clinical Trial of Leuprorelin acetate in Patients with SBMA Spinal and bulbar muscular atrophy (SBMA)Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks
Placebo subcutaneous injection every 4 weeks
Department of Neurology, Nagoya University School of MedicineNULLComplete: follow-up complete30years-old70years-oldMale40Phase 2Japan

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05478083
(ClinicalTrials.gov)
June 1, 20229/5/2022A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver DiseaseA GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver DiseasePolycystic Liver Disease;Autosomal Dominant Polycystic KidneyDrug: LeuprorelinUniversity Medical Center GroningenRadboud University Medical CenterRecruiting18 Years45 YearsFemale36Phase 2Netherlands
2EUCTR2020-005949-16-NL
(EUCTR)
25/10/202121/10/2021A study into the efficacy and toleratability of leuprorelin by patients suffering from severe polycystic liver diseaseA GnRH Agonist IN pre-menopausal women STudy to treat severe Polycystic Liver Disease - AGAINST-PLD Severe polycystic liver disease in female patients
MedDRA version: 20.1;Level: PT;Classification code 10048834;Term: Polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Classification code 10083939;Term: Autosomal dominant polycystic liver disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Lucrin
Product Name: Lucrin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
36Phase 2Netherlands

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
2NCT03963752
(ClinicalTrials.gov)
August 15, 201922/5/2019Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western MedicineEvidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western MedicineIdiopathic Precocious PubertyDrug: Ziyinxiehuo Granules Herbs;Drug: Megestrol Acetate Tablet;Drug: Leuprorelin Acetate 3.75mg InjectionChildren's Hospital of Fudan UniversityNULLRecruiting5 Years8 YearsFemale164Phase 4China
3NCT02993926
(ClinicalTrials.gov)
June 24, 201713/12/2016A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese ParticipantsAn Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious PubertyCentral Precocious PubertyDrug: Enantone;Drug: GnRH agonistTakedaNULLCompletedN/AN/AAll108China
4NCT02427958
(ClinicalTrials.gov)
August 7, 201523/4/2015A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese ParticipantsAn Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious PubertyCentral Precocious PubertyDrug: LeuprorelinTakedaNULLCompleted1 Year9 YearsAll307Phase 4China
5NCT03316482
(ClinicalTrials.gov)
June 11, 201512/10/2017Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious PubertyA Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious PubertyCentral Precocious PubertyDrug: Leuplin DPS 11.25mgJin Soon HwangNULLCompleted4 Years9 YearsAll58Phase 4Korea, Republic of
6NCT02920515
(ClinicalTrials.gov)
September 201216/8/2016Study of Comprehensive Diagnosis and Treatment for Children Precocious PubertyMulti-site Study of Comprehensive Treatment for Children Precocious PubertyCentral Precocious PubertyDrug: Triptorlin or Leuprorelin;Drug: Zhibo dihuang pills;Drug: Dabu ying pillsRuijin HospitalShanghai Children's Hospital;Shanghai Children's Medical Center;Xin Hua Hospital;Shanghai Children's Hospital;Shanghai Children's Medical Center;Xin Hua HospitalCompleted2 Years14 YearsFemale740Phase 4NULL
7EUCTR2014-004495-36-Outside-EU/EEA
(EUCTR)
28/11/2014A study of Lupron Depot Lupron Depot in treatment of central premature pubertyStudy of Lupron Depot in the Treatment of 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
55United States
8EUCTR2014-004493-42-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
9EUCTR2014-004494-16-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