drugset / Trial / NCT00564850

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

NCT00564850

Phase 3 Completed 37 enrolled Ipsen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-10
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Triptorelin Other / unclassified 11.25 mg Intramuscular

Indications