At a glance
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An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 278 participants across 23 sites in 10 countries.
Detailed Summary
The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.
Study Details
Timeline
Interventions
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.
Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.