182
Participants
Start Date
August 31, 2009
Primary Completion Date
March 31, 2011
Study Completion Date
March 31, 2011
Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
Bicalutamide
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
Hospital St Jan Brugge, Bruges
Institut Jules Bordet, Brussels
University Hospitals Leuven, Leuven
St. Elisabethziekenhuis, Turnhout
Aalborg Sygehus syd, Aalborg
Århus Universitetshospital, Skejby, Aarhus
Herlev Hospital, Ballerup Municipality
Regionhospitalet Holstebro, Holstebro
Sygehus Syd, Næstved Sygehus, Næstved
Roskilde Sygehus, Roskilde
HYKS/kirurgian klin./urologia, Helsinki
KYS/kirurgian klin (Kuopio), Kuopio
OYS/kirurgian klinik, Oulu
TAYS/kirurgian klinik, Tampere
Azienda Ospedaliero Universitaria Ospedali riuniti, Ancona
Azienda Ospedaliera S. Giuseppe Moscaaati, Avellino
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna, Bologna
U.O. Di Urologia - Spedali Civili di Brescia, Brescia
Clinica Urologica 1 Universita. Firensa, Florence
Fondazione IRCCS Istituto Nazionale Tumori, Milan
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, Milan
Azienda Ospedaliera Universitaria Federico II, Napoli
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo, Palermo
Clinica Urologica - Azienda Ospedaliera di Perugia, Perugia
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma, Roma
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette, Torino
Moelv spesialistsenter, Moelv
Aker Universitetssykehus HF, Oslo
Det Norske Radiumhospitalet HF, Oslo
St Olavs Hospital HF, Trondheim
Hospital Fernando da Fonseca, Amadora
Hospitais Universidade Coimbra, Coimbra
Centro Hospitalar Lisboa Norte, Hospital Santa Maria, Lisbon
Hospital S.João, Porto
Investigational site, Gothenburg
SU/Sahlgrenska, Gothenburg
Helsingborgs Lasarett, Helsingborg
Universitetssjukhuset MAS, Malmo
Södertälje Sjukhus, Södertälje
Uppsala/Akademiska sjukhuset, Uppsala
Cerrahpasa Faculty of Medicine, Kocamustafapasa, Istanbul
Istanbul University Faculty of Medicine, ÇAPA, Istanbul
Marmara University Faculty of Medicine, Altunizade, Istanbul
Ankara University Faculty of Medicine, Sıhhıye - Ankara
Hacettepe University Faculty of Medicine, Sıhhıye - Ankara
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY