Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Collaborator: Ferring Pharmaceuticals Korea, Ltd.

Criteria

Inclusion Criteria:

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient

• Has completed the 7-month main trial, FE200486 CS42

Exclusion Criteria:

• Has been withdrawn/discontinued from the FE200486 CS42 trial

• A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.