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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Subject | Ozarelix | Protein / enzyme biologic | 65 mg | Subcutaneous |