13 completed, 1 active not recruiting, 1 recruiting, 1 unknown. 16 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 13, Active not recruiting 1, Recruiting 1, Unknown 1 |
Follow Puberty, Precocious: new trials by email Literature Review of Puberty, Precocious trials Research Report on Puberty, Precocious
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty intradermal needles, Ziyinxiehuo Granules of traditional Chinese Medicine - Precocious Puberty, Treatment | Phase 3 | Recruiting | Children's Hospital of Fudan University | 170 | 2024-09-15 | 2026-03-16 |
| A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) Debio 4326 - Central Precocious Puberty | Phase 3 | Active not recruiting | Debiopharm International SA | 56 | 2024-07-31 | 2026-10-23 |
| Evaluate the Efficacy and Safety of DWJ108J Leuprolide Acetate 11.25 MG/ML - Central Precocious Puberty | Phase 3 | Unknown | Daewoong Pharmaceutical Co. LTD. | 79 | 2023-08-01 | 2023-09-06 |
| Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide - Puberty; Precocious, Central | Phase 3 | Completed | Foresee Pharmaceuticals Co., Ltd. | 94 | 2023-06-02 | 2026-07-20 |
| A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty. Triptorelin Pamoate - Central Precocious Puberty | Phase 3 | Completed | Ipsen | 66 | 2021-08-10 | 2025-02-19 |
| Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. Triptorelin pamoate 15mg - Central Precocious Puberty | Phase 3 | Completed | Ipsen | 32 | 2021-03-27 | 2024-08-01 |
| A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP) Leuprolide Acetate (LA) - Central Precocious Puberty (CPP) | Phase 3 | Completed | AbbVie | 45 | 2018-10-24 | 2024-05-29 |
| Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty Leuprolide Acetate 45 mg - Precocious Puberty, Central | Phase 3 | Completed | Tolmar Inc. | 64 | 2015-08-31 | 2020-06-02 |
| Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty Triptorelin - Central Precocious Puberty | Phase 3 | Completed | Debiopharm International SA | 44 | 2012-04-01 | 2017-07-28 |
| Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls Triptorelin acetate and Gonadorelin acetate, Gonadorelin acetate and Triptorelin acetate - Central Precocious Puberty, Sexual Precocity | Phase 3 | Completed | Hospital de Niños R. Gutierrez de Buenos Aires | 46 | 2009-12-01 | 2021-01-06 |
| Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty Leuprolide Acetate 3 Month Depot - Precocious, Leuprolide Acetate | Phase 3 | Completed | AbbVie (prior sponsor, Abbott) | 72 | 2008-12-01 | 2014-01-09 |
| A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg - Puberty, Precocious | Phase 3 | Completed | Abbott | 84 | 2008-06-01 | 2011-11-02 |
| Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study Triptorelin (I.N.N.) - Precocious Puberty | Phase 3 | Completed | Ipsen | 35 | 2008-04-01 | 2019-01-15 |
| Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty Triptorelin pamoate 11.25mg (Decapeptyl® SR) - Precocious Puberty | Phase 3 | Completed | Ipsen | 37 | 2007-10-01 | 2022-10-12 |
| Histrelin Subcutaneous Implant in Children With Central Precocious Puberty Histrelin Subcutaneous Implant - Central Precocious Puberty | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 36 | 2004-09-01 | 2021-01-08 |
| Study of Lupron Depot In The Treatment of Central Precocious Puberty Lupron (leuprolide acetate) - Puberty, Precocious | Phase 3 | Completed | Abbott | 55 | 1991-01-01 | 2011-04-12 |
Endocrine System Diseases (16) · Gonadal Disorders (16)
Leuprolide (7) · Triptorelin Pamoate (5) · Medicine, Chinese Traditional (1) · histrelin (1)
Ipsen (4) · Abbott (2) · Debiopharm International SA (2) · AbbVie (1) · AbbVie (prior sponsor, Abbott) (1) · Children's Hospital of Fudan University (1) · Daewoong Pharmaceutical Co. LTD. (1) · Endo USA Inc., a Keenova Therapeutics Company (1) · Foresee Pharmaceuticals Co., Ltd. (1) · Hospital de Niños R. Gutierrez de Buenos Aires (1) · Tolmar Inc. (1)
United States (8) · China (4) · Puerto Rico (4) · Argentina (3) · Chile (3) · Mexico (3) · France (2) · Brazil (1) · Canada (1) · New Zealand (1) · South Korea (1) · Taiwan (1)
Barry Reiner, MD (1) · Bassem Elmankabadi (1) · David Domek, MD (1) · Dennis Brenner, MD (1) · Diane Merritt, MD (1) · Douglas Rogers, MD (1) · Erica A Eugster, MD (1) · Erica Eugster, MD (1) · Fernando Cassorla, MD (1) · Gad Kletter, MD (1) · Galal Salem, MD (1) · Heidi Shea, MD (1)
PMID 21860633, PMID 22344198, PMID 24295437, PMID 24926950, PMID 25803268, PMID 32738042, PMID 39412628, PMID 41824265
2005 (1), 2008 (1)