An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
NCT ID: NCT00215683
Last Updated: 2015-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
137 participants
INTERVENTIONAL
2005-02-28
2009-11-30
Brief Summary
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The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).
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Detailed Description
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The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 80 mg
Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Degarelix 120 mg
Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Degarelix 160 mg
Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Interventions
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Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had completed the FE200486 CS12 study
Exclusion criterion:
* Had been withdrawn from the FE200486 CS12 study
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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UCL Saint Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Gasthuisberg, Urology Department
Leuven, , Belgium
Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, , Germany
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
Mannheim, , Germany
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
Budapest, , Hungary
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
Budapest, , Hungary
Pez Aladar County Hospital, Dept. of Urology
Győr, , Hungary
Bács-Kiskun County Hospital, Dept. of Urology
Kecskemét, , Hungary
BAZ County Hospital, Dept of Urology
Miskolc, , Hungary
Hospital of Local Government of Szeged, Dept. of Urology
Szeged, , Hungary
MÁV Hospital, Dept. of Urology
Szolnok, , Hungary
Academic Medical Center, Dept. of Urology
Amsterdam, , Netherlands
Atrium MC, Dept. of Urology
Heerlen, , Netherlands
"Prof.Dr.Th.Burghele" Hospital - Bucharest
Bucharest, , Romania
"Sf. Ioan" Emergency Hospital - Urology Department
Bucharest, , Romania
CF2 Hospital - Bucharest, Urology Department
Bucharest, , Romania
Fundeni Clinical Institute - Bucharest, Urology Department
Bucharest, , Romania
Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
Moscow, , Russia
Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
Moscow, , Russia
Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
Moscow, , Russia
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
Moscow, , Russia
"Andros" Urology Clinic, 36A, Lenina St.
Saint Petersburg, , Russia
City Hospital #15, Urology Department
Saint Petersburg, , Russia
City Hospital #26, Urology Department
Saint Petersburg, , Russia
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
Saint Petersburg, , Russia
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, , Russia
St. Petersburg Pavlov Medical School, Urology Department
Saint Petersburg, , Russia
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
Saint Petersburg, , Russia
Glenwood Hospital
Durban, , South Africa
WITS Medical School, Level 9
Parktown, , South Africa
401 B Medical Centre
Pietermaritzburg, , South Africa
Pretoria Urology Hospital, Suite 2, Hatfield
Pretoria, , South Africa
Sunninghill Clinic, Suite 3
Sunninghill, , South Africa
Countries
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Other Identifiers
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FE200486 CS12A
Identifier Type: -
Identifier Source: org_study_id
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