288
Participants
Start Date
October 31, 2010
Primary Completion Date
December 31, 2011
Study Completion Date
January 31, 2012
Degarelix
The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Goserelin acetate
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
University of Colorado School of Medicine, Aurora
The Urology Center of Colorado, Denver
Urology Associates of Dover, PA, Dover
South Florida Medical Research, Aventura
Urology Group of New Mexico, PC, Albuquerque
Carolina Urologic Research Center, Myrtle Beach
Urology San Antonio Research, Pa, San Antonio
Seattle Urology Research Center, Burien
AZ Groeninge - Campus Sint-Maarten, Kortrijk
Jonathan Giddens Medicine Professional Corporation, Brampton
Southern Interior Medical Research Inc., Kelowna
Mor Urology, Inc., Newmarket
Investigational site, Scarborough
Investigational site, Toronto
Urocentrum Brno, Brno
Nemocnice Jindrichuv Hradec, a.s., Jindřichův Hradec
Kromerizska nemocnice a.s., Kroměříž
Fakultni nemocnice v Motole, Praha 5, Prague
Vseobecna fakultni nemocnice v Praze, Praha 2, Prague
Krajska nemocnice T. Bati a.s., Zlín
ODL Terveys Oy, Oulu
Pohjois-Karjalan keskussairaala, Tampere
Tampereen yliopistollinen sairaala, Tampere
Gemeinschaftspraxis Rudolph & Wörner, Kirchheim
Urologische Studienpraxis, Nürtingen
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház, Budapest
Fövárosi Önkormányzat uzsoki utcai Kórház, Budapest
Semmelweis Egyetem, Budapest
Dombóvári Szent Lukács Egészségügyi Nonprofit Kft., Dombóvár
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft, Miskolc
Pécsi Tudományegyetem, Pécs
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged
Jávorszky Ödön Kórház, Vác
Hospital Christus Muguerza del Parque, Chihuahua, Chih.
Hospital Angeles Culiacan, Culiacan, Sinaloa
Consultorio de Especialidad en Urologia Privado, Durango
Médica Sur, S.A.B. de C.V., Mexico City
Hospital Angeles Lindavista, Mexico City, DF
Consultorio Medico, Zapopan, Jalisco
Catharina-ziekenhuis, Eindhoven
MC Haaglanden, The Hague
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego, Bialystok
Centrum Medyczne Medur Sp. z o.o., Bielsko-Biala
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku, Słupsk
Private Medical Center SRL, Arad
Brasov Emergency Clinical County Hospital, Brasov
"Prof. Dr. Th. Burghele Clinical Hospital", Bucharest
"Sfantul Ioan Emergency Clinical Hospital", Bucharest
Dinu Uromedica, Bucharest
Fundeni Clinical Institute of Uronephrology and Renal Transplantation, Bucharest
PROVITA 2000 Medical Center, Constanța
"Dr. C.I. Parhon Clinical Hospital", Iași
Vita Care Flav Medical Center, Piteşti
Sibiu Emergency Clinical County Hospital, Sibiu
Dnipropetrovsk State Medical Academy, Dnipropetrovsk
Donetsk Regional Clinical Territorial Medical Association, Donetsk
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval, Kharkiv
Kyiv City Clinical Hospital #3, Kyiv
Odesa Regional Clinical Hospital, Odesa
"Municipal Institution Zaporizhzhia Regional Clinical Hospital", Zaporizhzhya
Ipswich Hospital, Ipswich
The Royal Marsden NHS Foundation Trust, Sutton
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY