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 : 29 / 薬物数 : 44 - (DrugBank : 14) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 15
| 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 | NCT05341115 (ClinicalTrials.gov) | March 20, 2023 | 18/4/2022 | A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty | An 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 Puberty | Drug: Leuprorelin Acetate Depot 3M | Takeda | NULL | Not yet recruiting | N/A | 9 Years | All | 80 | Phase 4 | China |
| 2 | 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 | Completed | N/A | 10 Years | All | 66 | Phase 3 | China |
| 3 | 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 | Completed | N/A | 10 Years | All | 32 | Phase 3 | China |
| 4 | 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 | 45 | Phase 3 | United States;Puerto Rico |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 | |||
| 13 | 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 | ||||
| 14 | 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 |