Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE3
INTERVENTIONAL
NCT04736602
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.
Interventions
Name:
Triptorelin pamoate 15mg
Type:
DRUG
Description:
Intramuscular injection (IM)
Primary Outcomes
Measure:
Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation
TimeFrame:
At Month 3
Description:
The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (IV) injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels.
Trial Information
NCT ID
NCT04736602
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025