An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients Requiring Androgen Ablation Therapy
Inclusion Criteria:
- Has given written informed consent before any trial-related activity is performed. A
trial-related activity is defined as any procedure that would not have been performed
during the normal management of the patient
- Has completed the 7-month main trial, FE200486 CS42
Exclusion Criteria:
- Has been withdrawn/discontinued from the FE200486 CS42 trial
- A patient may also not be entered into the CS42A trial at the discretion of the
investigator due to safety or lack of efficacy concerns (LH or PSA response) in the
CS42 trial.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Outcome Description:
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal
Outcome Time Frame:
From baseline (day 0) to end of treatment (up to day 364)
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
Korea: Food and Drug Administration
Study ID:
FE200486 CS42A
NCT ID:
NCT01215513
Start Date:
September 2010
Completion Date:
April 2012
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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