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

NCT05493709 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Puberty; Precocious, Central

Interventions

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).

Sponsors & Collaborators

  • QPS Holdings LLC

    collaborator INDUSTRY

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Bassem Elmankabadi · Foresee Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2025-11-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • China
  • Puerto Rico
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493709 on ClinicalTrials.gov