NCT05341115

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.

Detailed description

The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP. The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration: • Leuprorelin Acetate Depot 3M 11.25 mg Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination. This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Leuprorelin Acetate Depot 3M	Leuprorelin Acetate Depot 3M SC injections.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-12-19
• Completion: 2025-03-10
• First posted: 2022-04-22
• Last updated: 2026-01-13
• Results posted: 2026-01-13

Locations

5 sites across 1 country: China