Status:
TERMINATED
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males aged 18 or over
- Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
- Has completed Study FE200486 CS07
- Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00215657
Start Date
March 1 2003
End Date
March 1 2006
Last Update
May 20 2011
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