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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Liver Function Tests
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.
Clinical Development Support
Denmark: The Ministry of the Interior and Health