NCT01467882

Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

An Open-label, Non-comparative, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Triptorelin Pamoate (Embonate) 22.5 mg 6-month Formulation in Patients Suffering From Central (Gonadotropin-dependent) Precocious Puberty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).

Conditions

• Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Triptorelin	Powder and solution for solution for injection

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-08-01
• Completion: 2014-07-01
• First posted: 2011-11-09
• Last updated: 2017-07-28
• Results posted: 2015-09-04

Locations

13 sites across 3 countries: United States, Chile, Mexico