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

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.

NCT Number	NCT06926933
Lead Sponsor	HanAll BioPharma Co., Ltd.
Conditions	CPP
Enrollment	50 participants
Start Date	2024-12-12
Primary Completion	2026-06-15 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-08