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
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.
⁃ Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation \> 5 IU/L
⁃ A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older \
• under 9 years of age) Girl (4 years of age or older \
• under 8 years of age) Tanner Stage : Level 2 or higher
⁃ Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
⁃ Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
⁃ Children with a body weight of more than 20 kg at screening
⁃ Children have a bone age that is ≥1 year older than their chronological age at screening
⁃ A signed written consent form by a legal representative who has been informed about this study