drugset / Trial / NCT01252693

International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer

NCT01252693

Phase 2 Completed 203 enrolled Spectrum Pharmaceuticals, Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days study. Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry.

Timeline

Start
2010-11
Primary completion
2014-09
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Goserelin Other / unclassified 3.6 mg Subcutaneous
Subject Ozarelix Protein / enzyme biologic 65 mg Subcutaneous

Indications