Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE3
INTERVENTIONAL
NCT00564850
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
Interventions
Name:
Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Type:
DRUG
Description:
One intra muscular injection at day 1 and month 3.
Primary Outcomes
Measure:
Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L
TimeFrame:
3 months after the first injection of triptorelin pamoate 11.25 mg
Description:
Trial Information
NCT ID
NCT00564850
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025