Spots Global Cancer Trial Database for An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
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Trial Identification
Brief Title: An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Official Title: An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.
Study ID: NCT00215683
Conditions
Interventions
Study Description
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 Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
UCL Saint Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
UZ Gasthuisberg, Urology Department, Leuven, , Belgium
Vivantes Klinikum am Urban, Klinik für Urologie, Berlin, , Germany
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim, Mannheim, , Germany
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology, Budapest, , Hungary
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology, Budapest, , Hungary
Pez Aladar County Hospital, Dept. of Urology, Györ, , Hungary
Bács-Kiskun County Hospital, Dept. of Urology, Kecskemét, , Hungary
BAZ County Hospital, Dept of Urology, Miskolc, , Hungary
Hospital of Local Government of Szeged, Dept. of Urology, Szeged, , Hungary
MÁV Hospital, Dept. of Urology, Szolnok, , Hungary
Academic Medical Center, Dept. of Urology, Amsterdam, , Netherlands
Atrium MC, Dept. of Urology, Heerlen, , Netherlands
"Prof.Dr.Th.Burghele" Hospital - Bucharest, Bucharest, , Romania
"Sf. Ioan" Emergency Hospital - Urology Department, Bucharest, , Romania
CF2 Hospital - Bucharest, Urology Department, Bucharest, , Romania
Fundeni Clinical Institute - Bucharest, Urology Department, Bucharest, , Romania
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, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital), 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
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1, Moscow, , Russian Federation
City Hospital #15, Urology Department, St Petersburg, , Russian Federation
City Hospital #26, Urology Department, St Petersburg, , Russian Federation
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department, St Petersburg, , Russian Federation
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation, St Petersburg, , Russian Federation
St. Petersburg Pavlov Medical School, Urology Department, St Petersburg, , Russian Federation
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center, St Petersburg, , Russian Federation
"Andros" Urology Clinic, 36A, Lenina St., St. Petersburg, , Russian Federation
Glenwood Hospital, Durban, , South Africa
WITS Medical School, Level 9, Parktown, , South Africa
401 B Medical Centre, Pietermaritzburg, , South Africa
Pretoria Urology Hospital, Suite 2, Hatfield, Pretoria, , South Africa
Sunninghill Clinic, Suite 3, Sunninghill, , South Africa
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
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