Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

Central Precocious Puberty Clinical Trial

Official title: An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty—Part A and B

Status Recruiting

Clinical Trial Summary

Exploring the efficacy in Leuprolide 45mg in slowing down or reversing Central Precocious Puberty in girls ages 2-8 and boys ages 2-9.

Clinical Trial Description

Primary Objectives Determine the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with CPP.

Secondary Objectives

• Evaluate the safety and tolerability of leuprolide acetate 45 mg for injectable suspension in children with CPP

• Characterize the burst kinetics of leuprolide acetate 45 mg after the first administration

• Characterize the pharmacodynamic (PD) relationship of leuprolide serum concentrations to concentrations of serum LH, FSH and to testosterone/estradiol

• Assess percent changes in height velocity and bone age progression after the first administration

• Assess changes in physical signs of puberty as measured by changes in Tanner stages or in changes or onset of menses

• Determine the dosing interval (5 or 6 months) at which leuprolide acetate is able to suppress LH concentration to <4 mIU/mL (after GnRHa stimulation test), as data permit ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

• NCT number: NCT02811471
• Study type: Interventional
• Source: Nemours Children's Clinic
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2016
• Completion date: July 2018