Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE3
INTERVENTIONAL
NCT05029622
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).
Interventions
Name:
Triptorelin Pamoate
Type:
DRUG
Description:
Triptorelin 6-month formulation for IM on day 1 and Month 6.
Primary Outcomes
Measure:
Percentage of Participants With Luteinising Hormone (LH) Suppression
TimeFrame:
At Month 6
Description:
LH response was defined as a peak LH \<=5 international units per liter (IU/L) after intravenous (IV) gonadotropin-releasing hormone (GnRH) stimulation. The GnRH stimulation test was performed by using an 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. Percentage of response was calculated by number of participants in the specified category divided by number of participants in the analysis population multiplied by 100.
Trial Information
NCT ID
NCT05029622
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025