A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
- Registration Number
- NCT00967018
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 77
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Degarelix 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables Up to 22.5 months The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Up to 22.5 months This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Hospital Universitari Vall d´Hebron
🇪🇸Barcelona, Spain
Centre Paul Strauss
🇫🇷Strassbourg, France
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
Centre Leon Berard
🇫🇷Lyon, France
Hôpital Tenon
🇫🇷Paris, France
Institut de Cancérologie de la Loire
🇫🇷Saint Priest en Jarez, France
Centre de radiologie Saint Louis
🇫🇷Toulon, France
Clinica Urologica - Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
🇮🇹Torino, Italy
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
🇵🇹Lisboa, Portugal
Fundación Puigvert
🇪🇸Barcelona, Spain
Hospital Universitario Principe de Asturias
🇪🇸Alcalá de Henares-Madrid, Spain
Fundacion Hospital Alcorcón
🇪🇸Alcorcon, Spain
Hospital S.João
🇵🇹Porto, Portugal
Hospital universitario Ramón y Cajal
🇪🇸Madrid, Spain
SU/Sahlgrenska
🇸🇪Göteborg, Sweden
Helsingborgs Lasarett
🇸🇪Helsingborg, Sweden
Hospital Xeral de Vigo
🇪🇸Vigo, Spain
Hospital Manacor
🇪🇸Manacor, Spain
Investigational site
🇸🇪Göteborg, Sweden
Universitetssjukhuset MAS
🇸🇪Malmö, Sweden
Hospital Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Södertälje Sjukhus
🇸🇪Södertälje, Sweden
Uppsala/Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Ankara University Faculty of Medicine - Sıhhıye
🇹🇷Ankara, Turkey
Cerrahpasa Faculty of Medicine - Kocamustafapasa
🇹🇷Istanbul, Turkey
Istanbul University Faculty of Medicine - ÇAPA
🇹🇷Istanbul, Turkey
Marmara University Faculty of Medicine - Altunizade
🇹🇷Istanbul, Turkey
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Fundación IVO
🇪🇸Valencia, Spain
Institut Bergonié
🇫🇷Bordeaux Cedex, France
Hopital Jean Minjoz
🇫🇷Besancon, France
St. Elisabethziekenhuis
🇧🇪Turnhout, Belgium
Centre Francois Baclesse
🇫🇷Caen, France
Hospital Doce de Octubre
🇪🇸Madrid, Spain
CHU Henri Mondor
🇫🇷Creteil, France
Centre Oscar Lambret
🇫🇷Lille, France
Hopital de la Timone
🇫🇷Marseille, Cedex, France
CRLC Val d' Aurelle - Oncology Radiotherapy
🇫🇷Montpellier, France
Clinique Francheville
🇫🇷Perigueux, France
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
🇫🇷Saint Herblain Cedex, France
Hôpital Saint Louis - Radiotherapy Departement
🇫🇷Paris, France
Clinique du Parc
🇫🇷Toulouse, France
CHU La Milétrie - Oncology Radiotherapy
🇫🇷Poitiers, France
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
🇮🇹Bologna, Italy
Clinique Saint Brieuc
🇫🇷St Brieuc Cedex, France
Azienda Ospedaliero Universitaria Ospedali riuniti
🇮🇹Ancona, Italy
Clinica Urologica 1 Universita Firenze
🇮🇹Firenze, Italy
IGR
🇫🇷Villejuif, France
Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹Milano, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
🇮🇹Palermo, Italy
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
🇮🇹Roma, Italy
Hospital Fernando da Fonseca
🇵🇹Amadora, Portugal
Hospitais Universidade Coimbra
🇵🇹Coimbra, Portugal
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Clinico Universitario S. Carlos
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain