NCT06926933

Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty

An Open Label, Single-group, Multicenter Study on the Efficacy and Safety of Leuprolide Acetate 45 mg for Injectable Suspension-controlled Release in Subjects With Central (Gonadotropin-dependent) Precocious Puberty

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP. Screening tests are performed after the subject agrees in writing to participate in the clinical trial, and subjects who meet the inclusion criteria and do not fall under the exclusion criteria are enrolled in the study. The target patients in this study are pediatric patients who have been diagnosed with CPP but have not yet received GnRH agonist treatment, and all subjects perform GnRH stimulation tests to confirm their CPP diagnosis.

Conditions

• CPP

Interventions

Type	Name	Description
DRUG	Eligard® 45 mg	45 mg of leuprolide acetate

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-04-20
• Completion: 2027-10-30
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

9 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study