NCT01656161

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: * achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and * in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Triptorelin embonate 22.5 mg

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-08-02
• Last updated: 2015-09-15
• Results posted: 2015-09-15

Locations

10 sites across 1 country: South Africa