Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT05493709
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
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.
Interventions
Name:
Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
Type:
DRUG
Description:
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
Primary Outcomes
Measure:
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
TimeFrame:
48 weeks
Description:
The percentage of patients with serum LH concentrations \< 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
Trial Information
NCT ID
NCT05493709
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Foresee Pharmaceuticals Co., Ltd.
Last Updated
December 15, 2025