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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 (Gonadotrop

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

Detailed Summary: 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.
Sponsor: Tolmar Inc.

Current Primary Outcome: Percentage of Participants with Suppression of Peak-Stimulated Luteinizing Hormone at 6 months. [ Time Frame: 6 months ]

Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4mIU/mL. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of subjects with suppression of luteinizing hormone measured by blood levels. [ Time Frame: Up to 12 months ]

Original Secondary Outcome: Same as current

Information By: Tolmar Inc.

Dates:
Date Received: May 5, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: March 24, 2017
Last Verified: March 2017