Overview

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

Status:
Completed

Trial end date:
2013-08-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Debiopharm International SA

Collaborator:

Quintiles, Inc.

Treatments:

Triptorelin Pamoate