Status:
COMPLETED
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degare...
Detailed Description
Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated wit...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
- Had completed the FE200486 CS12 study
- Exclusion criterion:
- Had been withdrawn from the FE200486 CS12 study
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00215683
Start Date
February 1 2005
End Date
November 1 2009
Last Update
April 1 2015
Active Locations (34)
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1
UCL Saint Luc
Brussels, Belgium
2
UZ Gent
Ghent, Belgium
3
UZ Gasthuisberg, Urology Department
Leuven, Belgium
4
Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, Germany