A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Weeks 1,2,4,8,12,16,20,24
No
Clinical Development Support
Study Director
Ferring Pharmaceuticals
United Kingdom: Medicines and Healthcare Products Regulatory Agency
FE200486 CS02
NCT00819247
March 2001
August 2002
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