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

Precocious Puberty, Central 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

Status Completed

Clinical Trial Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Clinical Trial Description

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty. ;

Related Conditions & MeSH terms

• Precocious Puberty, Central
• Puberty, Precocious

• NCT number: NCT02452931
• Study type: Interventional
• Source: Tolmar Inc.
• Status: Completed
• Phase: Phase 3
• Start date: August 31, 2015
• Completion date: September 5, 2018