Status:
COMPLETED
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
- Has successfully completed the main study.
- Exclusion Criterion:
- \- Has been withdrawn from the main study.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00268892
Start Date
January 1 2006
End Date
December 1 2009
Last Update
December 24 2010
Active Locations (23)
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1
UZ Gasthuisberg Leuven
Leuven, Belgium
2
Helsinki University Hospital, Maria Hospital, Building 11
Helsinki, Finland
3
Central Hospital, North Karelian
Joensuu, Finland
4
Oulu University Hospital
Oulu, Finland