An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months
Degarelix was not FDA regulated at the time of the trial. After completion of the trial
degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Number of patients who achieved a testosterone level considered a castration level.
Clinical Development Support
Russia: FSI Scientific Center of Expertise of Medical Application