76. 下垂体性ゴナドトロピン分泌亢進症 Pituitary gonadotropin secretion hyperthyroidism Clinical trials / Disease details
臨床試験数 : 28 / 薬物数 : 46 - (DrugBank : 14) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 19
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05029622 (ClinicalTrials.gov) | August 10, 2021 | 9/8/2021 | A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. | A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty. | Central Precocious Puberty | Drug: Triptorelin Pamoate | Ipsen | NULL | Recruiting | N/A | 10 Years | All | 66 | Phase 3 | China |
| 2 | NCT04736602 (ClinicalTrials.gov) | March 27, 2021 | 29/1/2021 | Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. | An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty | Central Precocious Puberty | Drug: Triptorelin pamoate 15mg | Ipsen | NULL | Active, not recruiting | N/A | 10 Years | All | 32 | Phase 3 | China |
| 3 | ChiCTR2100047299 | 2020-12-01 | 2021-06-12 | The use of morning urinary gonadotropins and sexual hormones in the diagnosis and monitoring treatment of central precocious puberty | The use of morning urinary gonadotropins and sexual hormones in the diagnosis and monitoring treatment of central precocious puberty | precocious puberty | Gold Standard:gonadotropin releasing hormone stimulation test ;Index test:luteinizing hormone, follicle stimulating hormone, estradiol, prolactin, progesterone, testosterone, and human chorionic gonadotropin; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 3 | 10 | Female | Target condition:200;Difficult condition:100 | China | |
| 4 | ChiCTR2000038202 | 2020-09-01 | 2020-09-13 | AMH combined INHB for the diagnosis of female central precocious puberty | AMH combined INHB for the diagnosis of female central precocious puberty | Central precocious puberty | Gold Standard:GnRHa provoctive test;Index test:Anti Mullerian hormone, Inhibin B; | Capital Institute of Pediatrics | NULL | Recruiting | 5 | 8 | Female | Target condition:150;Difficult condition:150 | China | |
| 5 | ChiCTR2000034464 | 2020-09-01 | 2020-07-05 | First Morning Voided Urinary Gonadotropin Measurements for the Early Screening, Diagnosis and Follow-up of CPP Patients | First Morning Voided Urinary Gonadotropin Measurements for the Early Screening, Diagnosis and Follow-up of CPP Patients | Central precocious puberty | Gold Standard:Clinical outcome by CPP diagnostic standards;Index test:morning urine GN; | Department of Pediatrics, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | NULL | Pending | 6 | 12 | Both | Target condition:400;Difficult condition:6000 | China | |
| 6 | NCT03963752 (ClinicalTrials.gov) | August 15, 2019 | 22/5/2019 | Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine | Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine | Idiopathic Precocious Puberty | Drug: Ziyinxiehuo Granules Herbs;Drug: Megestrol Acetate Tablet;Drug: Leuprorelin Acetate 3.75mg Injection | Children's Hospital of Fudan University | NULL | Recruiting | 5 Years | 8 Years | Female | 164 | Phase 4 | China |
| 7 | NCT03695237 (ClinicalTrials.gov) | October 24, 2018 | 2/10/2018 | A 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) | AbbVie | NULL | Active, not recruiting | 2 Years | 11 Years | All | 40 | Phase 3 | United States;Puerto Rico |
| 8 | ChiCTR1800017120 | 2018-08-01 | 2018-07-12 | A real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls | A real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls. | precocious puberty | Case series:rhGH therapy; | The Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 3 | 12 | Female | Case series:700; | China | |
| 9 | ChiCTR1800016768 | 2018-06-25 | 2018-06-22 | A real world study on the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls | A real world study on the efficacy and safety of the combination therapy of GnRHa and rhGH in the treatment of central precocious puberty or rapid progressive adolescent girls | Central precocious puberty or rapid progressive adolescence | Case series:GnRHa combined with rhGH; | The Children's Hospital, Zhe Jiang University School of Medcine | NULL | Recruiting | 6 | 12 | Female | Case series:700; | China | |
| 10 | NCT02993926 (ClinicalTrials.gov) | June 24, 2017 | 13/12/2016 | A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants | An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty | Central Precocious Puberty | Drug: Enantone;Drug: GnRH agonist | Takeda | NULL | Completed | N/A | N/A | All | 108 | China | |
| 11 | NCT02811471 (ClinicalTrials.gov) | June 2016 | 21/6/2016 | Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty | An 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 B | Central Precocious Puberty | Drug: Leuprolide | Nemours Children's Clinic | Tolmar Inc. | Recruiting | 2 Years | 9 Years | Both | 5 | Phase 3 | United States |
| 12 | NCT02974270 (ClinicalTrials.gov) | June 2016 | 19/5/2016 | Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate | Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate | Precocious Puberty, Central | Drug: Leuprolide | Kyungpook National University | NULL | Recruiting | N/A | 9 Years | Both | 100 | Phase 4 | Korea, Republic of |
| 13 | NCT02452931 (ClinicalTrials.gov) | August 31, 2015 | 5/5/2015 | Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty | An 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 | Precocious Puberty, Central | Drug: Leuprolide Acetate 45 mg | Tolmar Inc. | NULL | Completed | 2 Years | 9 Years | All | 64 | Phase 3 | United States;Argentina;Canada;Chile;Mexico;New Zealand |
| 14 | NCT02427958 (ClinicalTrials.gov) | August 7, 2015 | 23/4/2015 | A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants | An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty | Central Precocious Puberty | Drug: Leuprorelin | Takeda | NULL | Completed | 1 Year | 9 Years | All | 307 | Phase 4 | China |
| 15 | NCT03316482 (ClinicalTrials.gov) | June 11, 2015 | 12/10/2017 | Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty | A Multicenter, Open, Prospective Study to Evaluate the Safety and Efficacy of Leuprorelin Acetate DPS (Leuplin DPS) Treatment Quarterly in Patients With Central Precocious Puberty | Central Precocious Puberty | Drug: Leuplin DPS 11.25mg | Jin Soon Hwang | NULL | Completed | 4 Years | 9 Years | All | 58 | Phase 4 | Korea, Republic of |
| 16 | NCT02920515 (ClinicalTrials.gov) | September 2012 | 16/8/2016 | Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty | Multi-site Study of Comprehensive Treatment for Children Precocious Puberty | Central Precocious Puberty | Drug: Triptorlin or Leuprorelin;Drug: Zhibo dihuang pills;Drug: Dabu ying pills | Ruijin Hospital | Shanghai Children's Hospital;Shanghai Children's Medical Center;Xin Hua Hospital;Shanghai Children's Hospital;Shanghai Children's Medical Center;Xin Hua Hospital | Completed | 2 Years | 14 Years | Female | 740 | Phase 4 | NULL |
| 17 | NCT01467882 (ClinicalTrials.gov) | April 2012 | 7/11/2011 | Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty | An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty | Central Precocious Puberty | Drug: Triptorelin | Debiopharm International SA | NULL | Completed | 2 Years | 9 Years | All | 44 | Phase 3 | United States;Chile;Mexico |
| 18 | NCT01634321 (ClinicalTrials.gov) | July 2011 | 3/7/2012 | The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty | The 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 Study | Central Precocious Puberty | Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg) | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 4 Years | 9 Years | Both | 63 | Phase 4 | Korea, Republic of |
| 19 | NCT01278290 (ClinicalTrials.gov) | December 2009 | 14/1/2011 | Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls | Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls. | Central Precocious Puberty;Sexual Precocity | Diagnostic Test: Triptorelin acetate and Gonadorelin acetate;Diagnostic Test: Gonadorelin acetate and Triptorelin acetate | Hospital de Niños R. Gutierrez de Buenos Aires | NULL | Completed | 3 Years | 8 Years | Female | 46 | Phase 3 | Argentina |
| 20 | NCT00667446 (ClinicalTrials.gov) | December 2008 | 24/4/2008 | Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty | A 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 Puberty | Precocious;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 Puberty | Drug: Leuprolide Acetate 3 Month Depot | AbbVie (prior sponsor, Abbott) | NULL | Completed | N/A | N/A | All | 72 | Phase 3 | United States;Puerto Rico |
| 21 | NCT00635817 (ClinicalTrials.gov) | June 2008 | 7/3/2008 | A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty | A 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 Puberty | Puberty, Precocious | Drug: Leuprolide acetate 11.25 mg;Drug: Leuprolide acetate 30 mg | Abbott | NULL | Completed | 2 Years | 11 Years | All | 84 | Phase 3 | United States;Puerto Rico |
| 22 | NCT00438217 (ClinicalTrials.gov) | May 2006 | 21/2/2007 | Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children | Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children | Central Precocious Puberty | Drug: Triptorelin (GnRH agonists);Drug: Leuprolide (GnRH agonists) | University of Pisa | NULL | Recruiting | 1 Year | 18 Years | Both | 100 | Phase 4 | Italy |
| 23 | NCT00779103 (ClinicalTrials.gov) | September 2004 | 22/10/2008 | Histrelin Subcutaneous Implant in Children With Central Precocious Puberty | Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty | Central Precocious Puberty | Drug: Histrelin Subcutaneous Implant | Endo Pharmaceuticals | NULL | Completed | 2 Years | 10 Years | Both | 36 | Phase 3 | NULL |
| 24 | NCT00660010 (ClinicalTrials.gov) | January 1991 | 15/4/2008 | Study of Lupron Depot In The Treatment of Central Precocious Puberty | Study of Lupron Depot In The Treatment of Central Precocious Puberty | Puberty, Precocious | Drug: Lupron (leuprolide acetate) | Abbott | NULL | Completed | N/A | 10 Years | All | 55 | Phase 3 | United States |
| 25 | EUCTR2014-004495-36-Outside-EU/EEA (EUCTR) | 28/11/2014 | A study of Lupron Depot Lupron Depot in treatment of central premature puberty | Study 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 Abbott | NULL | NA | Female: yes Male: yes | 55 | United States | ||||
| 26 | EUCTR2015-001607-30-Outside-EU/EEA (EUCTR) | 24/04/2015 | Triptorelin 6-month formulation for children who mature too early because of a brain hormone | An open-label, non-comparative, multicenter study on the efficacy, safety, and pharmacokinetics of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in patients suffering from central (gonadotropin-dependent) precocious puberty - Triptorelin 6-month Formulation in Patients With Central Precocious Puberty | Central Precocious Puberty MedDRA version: 18.0;Level: PT;Classification code 10058084;Term: Precocious puberty;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | INN or Proposed INN: TRIPTORELIN Other descriptive name: Triptorelin embonate, Triptorelin pamoate | Debiopharm International, S.A. | NULL | NA | Female: yes Male: yes | 44 | United States;Chile;Mexico | ||||
| 27 | EUCTR2014-004493-42-Outside-EU/EEA (EUCTR) | 03/12/2014 | A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature puberty | A 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 Abbott | NULL | NA | Female: yes Male: yes | 80 | Phase 3 | United States;Puerto Rico | |||
| 28 | EUCTR2014-004494-16-Outside-EU/EEA (EUCTR) | 03/12/2014 | A clinical trial to determine safety and efficacy of Leuprolide Acetate 11.25mg and 30mg in children with central premature puberty | A 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 Abbott | NULL | NA | Female: yes Male: yes | 72 | United States;Puerto Rico |