A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
NCT ID: NCT00967018
Last Updated: 2013-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
77 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Degarelix
Interventions
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Degarelix
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Institut Jules Bordet
Brussels, , Belgium
St. Elisabethziekenhuis
Turnhout, , Belgium
Hopital Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
CHU Henri Mondor
Créteil, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital de la Timone
Marseille, , France
CRLC Val d' Aurelle - Oncology Radiotherapy
Montpellier, , France
Hôpital Saint Louis - Radiotherapy Departement
Paris, , France
Hôpital Tenon
Paris, , France
Clinique Francheville
Périgueux, , France
CHU La Milétrie - Oncology Radiotherapy
Poitiers, , France
Clinique Saint Brieuc
Saint-Brieuc, , France
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Centre de radiologie Saint Louis
Toulon, , France
Clinique du Parc
Toulouse, , France
IGR
Villejuif, , France
Azienda Ospedaliero Universitaria Ospedali riuniti
Ancona, , Italy
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
Bologna, , Italy
Clinica Urologica 1 Universita Firenze
Florence, , Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
Palermo, , Italy
Clinica Urologica - Azienda Ospedaliera di Perugia
Perugia, , Italy
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
Roma, , Italy
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
Torino, , Italy
Hospital Fernando da Fonseca
Amadora, , Portugal
Hospitais Universidade Coimbra
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
Lisbon, , Portugal
Hospital S.João
Porto, , Portugal
Hospital Universitario Principe de Asturias
Alcalá de Henares-Madrid, , Spain
Fundacion Hospital Alcorcón
Alcorcón, , Spain
Fundación Puigvert
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital Clinico Universitario S. Carlos
Madrid, , Spain
Hospital Doce de Octubre
Madrid, , Spain
Hospital universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Manacor
Manacor, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Virgen Macarena
Seville, , Spain
Fundación IVO
Valencia, , Spain
Hospital Xeral de Vigo
Vigo, , Spain
Investigational site
Gothenburg, , Sweden
SU/Sahlgrenska
Gothenburg, , Sweden
Helsingborgs Lasarett
Helsingborg, , Sweden
Universitetssjukhuset MAS
Malmo, , Sweden
Södertälje Sjukhus
Södertälje, , Sweden
Uppsala/Akademiska sjukhuset
Uppsala, , Sweden
Ankara University Faculty of Medicine - Sıhhıye
Ankara, , Turkey (Türkiye)
Cerrahpasa Faculty of Medicine - Kocamustafapasa
Istanbul, , Turkey (Türkiye)
Istanbul University Faculty of Medicine - ÇAPA
Istanbul, , Turkey (Türkiye)
Marmara University Faculty of Medicine - Altunizade
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EudraCT No: 2008-006827-29
Identifier Type: -
Identifier Source: secondary_id
FE200486 CS34
Identifier Type: -
Identifier Source: org_study_id
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