Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE3
INTERVENTIONAL
NCT02452931
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Leuprolide Acetate 45 mg
Type:
DRUG
Description:
Subcutaneous injection
Primary Outcomes
Measure:
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
TimeFrame:
6 months
Description:
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Trial Information
NCT ID
NCT02452931
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Tolmar Inc.
Last Updated
December 15, 2025