Status:
COMPLETED
Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients
Lead Sponsor:
Ferring Pharmaceuticals
Collaborating Sponsors:
Ferring Pharmaceuticals Korea, Ltd.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.
Eligibility Criteria
Inclusion
- 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
- Has been withdrawn/discontinued from the FE200486 CS42 trial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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01215513
Start Date
September 1 2010
End Date
April 1 2012
Last Update
May 22 2013
Active Locations (11)
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1
Korea University Hospital
Seoul, Anam-dong, Seongbuk-gu, South Korea
2
Seoul St. Mary's Hospital
Seoul, Banpo-dong, Seocho-gu, South Korea
3
Kyoungbuk National University Hospital
Daegu, Daegu, South Korea
4
Yonsei University Health System Gangnam Sevrance
Seoul, Eonguro, Gangnam-gu, South Korea