NCT00564850

Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty

Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Precocious Puberty

Interventions

Type	Name	Description
DRUG	Triptorelin pamoate 11.25mg (Decapeptyl® SR)	One intra muscular injection at day 1 and month 3.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-11-28
• Last updated: 2022-10-12
• Results posted: 2011-12-01

Locations

18 sites across 1 country: France