NCT05493709

Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Puberty; Precocious, Central

Interventions

Type	Name	Description
DRUG	Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide	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).

Timeline

• Start date: 2023-06-02
• Primary completion: 2025-11-01
• Completion: 2026-06-01
• First posted: 2022-08-09
• Last updated: 2025-09-19

Locations

41 sites across 4 countries: United States, China, Puerto Rico, Taiwan

Regulatory

• FDA-regulated drug study