An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 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 CS07; NCT00818623) and the
extension study FE200486 CS07A.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, 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:
Denmark: The Ministry of the Interior and Health
Study ID:
FE200486 CS07A
NCT ID:
NCT00215657
Start Date:
March 2003
Completion Date:
March 2006
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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