42
Participants
Start Date
April 30, 2009
Primary Completion Date
June 30, 2010
Study Completion Date
July 31, 2010
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 second and third doses of goserelin were administered on Days 31 and 59, respectively.
Bicalutamide
On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
Hospital Santiago de Compostela, Santiago de Compostela
Urologische Gemeinschaftspraxis, Hamburg
Hospital universitario Ramón y Cajal, Madrid
Hospital Clinico Universitario S. Carlos, Madrid
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid
Hospital Universitario Principe de Asturias, Alcalá de Henares-Madrid
Fundacion Hospital Alcorcón, Alcorcón
Hospital Universitario Central de Asturias, Oviedo
Hospital Xeral de Vigo, Vigo
Hospital Virgen Macarena, Seville
Wuppertaler Gemeinschaftspraxis, Wuppertal
Gemeinschaftspraxis, Borken
Hospital de Basurto, Bilbao (Bizkaia)
Gemeinschaftspraxis, Cologne
Klinikum Offenbach GmbH, Offenbach
Urologische Klinik Planegg, Planegg
Euromed Clinic, Fürth
Facharztpraxis für Urologie, Bamberg
Universitätsklinikum Dresden, Dresden
VITURO Gesellschaft für Klinische Studien, Leipzig
Complejo Hospitalario Universitario A Coruña, A Coruña
Fundación Puigvert, Barcelona
Hospital Manacor, Manacor
United Bristol Healthcare NHSTrust Bristol Royal Infirmary, Bristol
Falkirk and District Royal Infirmary, Falkirk
Southern General Hospital, Glasgow
Castle Hill Hospital, Hull
Whipps Cross University Hospital, London
The Royal Free Hospital, London
King's College Hospital, London
Derriford Hospital, Plymouth
Royal Hallamshire Hospital, Sheffield South, Sheffield
Sunderland Royal Hospital, Sunderland
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY