An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
- Registration Number
- NCT00215683
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).
- Detailed Description
Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).
The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix 80 mg Degarelix Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL). Degarelix 120 mg Degarelix Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL). Degarelix 160 mg Degarelix Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
- Primary Outcome Measures
Name Time Method Participants With Markedly Abnormal Change in Vital Signs and Body Weight 5 years Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Liver Function Tests 5 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Vivantes Klinikum am Urban, Klinik für Urologie
🇩🇪Berlin, Germany
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
🇩🇪Mannheim, Germany
Pez Aladar County Hospital, Dept. of Urology
🇭🇺Györ, Hungary
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
🇭🇺Budapest, Hungary
Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
🇷🇺Moscow, Russian Federation
Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
🇷🇺Moscow, Russian Federation
UZ Gasthuisberg, Urology Department
🇧🇪Leuven, Belgium
St. Petersburg Pavlov Medical School, Urology Department
🇷🇺St Petersburg, Russian Federation
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
🇷🇺Moscow, Russian Federation
UZ Gent
🇧🇪Gent, Belgium
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
🇷🇺St Petersburg, Russian Federation
"Andros" Urology Clinic, 36A, Lenina St.
🇷🇺St. Petersburg, Russian Federation
Bács-Kiskun County Hospital, Dept. of Urology
🇭🇺Kecskemét, Hungary
Hospital of Local Government of Szeged, Dept. of Urology
🇭🇺Szeged, Hungary
City Hospital #26, Urology Department
🇷🇺St Petersburg, Russian Federation
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
🇭🇺Budapest, Hungary
City Hospital #15, Urology Department
🇷🇺St Petersburg, Russian Federation
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
🇷🇺St Petersburg, Russian Federation
WITS Medical School, Level 9
🇿🇦Parktown, South Africa
401 B Medical Centre
🇿🇦Pietermaritzburg, South Africa
UCL Saint Luc
🇧🇪Bruxelles, Belgium
MÁV Hospital, Dept. of Urology
🇭🇺Szolnok, Hungary
"Prof.Dr.Th.Burghele" Hospital - Bucharest
🇷🇴Bucharest, Romania
CF2 Hospital - Bucharest, Urology Department
🇷🇴Bucharest, Romania
Academic Medical Center, Dept. of Urology
🇳🇱Amsterdam, Netherlands
BAZ County Hospital, Dept of Urology
🇭🇺Miskolc, Hungary
Atrium MC, Dept. of Urology
🇳🇱Heerlen, Netherlands
"Sf. Ioan" Emergency Hospital - Urology Department
🇷🇴Bucharest, Romania
Fundeni Clinical Institute - Bucharest, Urology Department
🇷🇴Bucharest, Romania
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
🇷🇺St Petersburg, Russian Federation
Glenwood Hospital
🇿🇦Durban, South Africa
Sunninghill Clinic, Suite 3
🇿🇦Sunninghill, South Africa
Pretoria Urology Hospital, Suite 2, Hatfield
🇿🇦Pretoria, South Africa
Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
🇷🇺Moscow, Russian Federation