Long-term Safety, Efficacy, and PROs: Phase 3 Study of Leuprolide Acetate 6-month IM Depot in Central Precocious Puberty
Abstract
Context: The long-term safety and efficacy of leuprolide acetate (LA) intramuscular (IM) depot in children with central precocious puberty (CPP) have not been examined. Objective: We evaluated the 144-week efficacy and safety of LA IM depot with 6-month dosing frequency for the treatment of CPP. Methods: Children with CPP received 45 mg LA IM depot in a phase 3, single-arm study (NCT03695237) that enrolled both treatment-naive (n = 27) and previously treated (n = 18) children (age: 7.8 ± 1.27 years). Outcomes included suppression of peak-stimulated LH (
Fields of Study & Subjects
Hypothalamic control of reproductive hormones
Ovarian function and disorders
Growth Hormone and Insulin-like Growth Factors
Publication details
- Journal / source
- Journal of the Endocrine Society
- Publisher
- The Endocrine Society
- Volume
- 10
- Issue
- 2
- Pages
- bvaf224–bvaf224
- Publication date
- 7 January 2026
- Language
- EN