Prostate Cancer Clinical Trial
Official title:
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was
to be treated until he was discontinued or withdrawn from the study, or a marketing
authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5
years.
Participants who completed the main FE200486 CS14 study initially continued with the same
dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160
mg (40 mg/mL) for all study participants.
The data include data from the participants who participated in both the main study
(FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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