NCT00245466

Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Detailed description

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 (FDA regulated intervention is therefore ticked "YES"). The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	Given as a subcutaneous injection once every 4 weeks.
DRUG	Degarelix	Given as a subcutaneous injection once every 4 weeks.
DRUG	Degarelix	Given as a subcutaneous injection once every 4 weeks.

Timeline

• Start date: 2001-10-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-10-28
• Last updated: 2011-05-20
• Results posted: 2009-06-11