clinical trial · NCT05493709
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
Foresee Pharmaceuticals Co., Ltd.·phase3·active not recruiting·n = 93
Puberty; Precocious, CentralLeuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
brief summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
started
Jun 2, 2023
primary completion
Nov 1, 2025
completion
Jun 1, 2026
last updated
Sep 19, 2025
detailed description
This is a multi-center, open-label, single-arm study. All subjects will be pediatric patients with central precocious puberty judged to be candidates for GnRH (gonadotropin releasing hormone) analog therapy, and all will receive two injections of FP-001 42 mg six-month apart in an unblinded fashion.
official title
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol