An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
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.
Inclusion Criteria:
- Has completed study treatment in study FE200486 CS02.
- Has completed visit 16 in study FE200486 CS02.
- Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Liver Function Tests
Outcome Description:
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United Kingdom: National Health Service
Study ID:
FE200486 CS02A
NCT ID:
NCT00245466
Start Date:
October 2001
Completion Date:
March 2006
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Androgen ablation therapy
- Prostatic Neoplasms
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