Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.

Inclusion Criteria:

• Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

• Has been withdrawn from the FE200486 CS14 study.