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

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.

Timeline

Start

2024-12-12

Primary completion

2026-06-15

Completion

2027-11-30

Drugs

Indications

No indication recorded.