NCT02452931

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Tolmar Inc. · Industry
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Precocious Puberty, Central

Interventions

Type	Name	Description
DRUG	Leuprolide Acetate 45 mg	Subcutaneous injection

Timeline

• Start date: 2015-08-31
• Primary completion: 2018-09-05
• Completion: 2018-09-05
• First posted: 2015-05-25
• Last updated: 2020-06-02
• Results posted: 2020-05-20

Locations

20 sites across 6 countries: United States, Argentina, Canada, Chile, Mexico, New Zealand