A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
NCT ID: NCT00451958
Last Updated: 2013-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
386 participants
INTERVENTIONAL
2007-03-31
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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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 80 mg / Degarelix 80 mg
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 subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
Degarelix 80 mg / Degarelix 80 mg
Degarelix 160 mg / Degarelix 160 mg
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 subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Degarelix 160 mg / Degarelix 160 mg
Leuprolide 7.5 mg / Degarelix 80 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 80 mg
Leuprolide 7.5 mg / Degarelix 160 mg
During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Leuprolide 7.5 mg / Degarelix 160 mg
Interventions
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Degarelix 80 mg / Degarelix 80 mg
Degarelix 160 mg / Degarelix 160 mg
Leuprolide 7.5 mg / Degarelix 80 mg
Leuprolide 7.5 mg / Degarelix 160 mg
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Signed informed consent
* The patients must have completed the FE 200486 CS21 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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Urology Centers Of Alabama
Homewood, Alabama, United States
South Orange County Medical Research Center
Laguna Hills, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associates Research
Englewood, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Investigational Site
Ocala, Florida, United States
Regional Urology
Shreveport, Louisiana, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Investigational Site
Carmel, New York, United States
North Urology Research
Concord, North Carolina, United States
Investigational Site
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
Urology San Antonio Research
San Antonio, Texas, United States
Seattle Urology Research Center
Burien, Washington, United States
Investigational Site
Kentville, Nova Scotia, Canada
The Female/Male Health Centres
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
Burlington Professional Centre
Burlington, Ontario, Canada
The Urology Research Centre
Burlington, Ontario, Canada
Investigational Site
Newmarket, Ontario, Canada
The Female/Male Health Centres
Oakville, Ontario, Canada
Urology South Shore Research
Greenfields, Quebec, Canada
Can-Med Clinical Research Inc
Victoria, , Canada
Urocentrum Brno
Brno, , Czechia
UROHELP - Bozetechova
Brno, , Czechia
Nemocnice Jindrichuv Hradec, a.s.
Jindřichův Hradec, , Czechia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Slezska nemocnice
Opava, , Czechia
Fakultni nemocnice v Motole, Prague5
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze, Prague2
Prague, , Czechia
Klinikum Mannheim Universitätsklinikum GmbH
Mannheim, , Germany
Klinikum der Universität Regensburg
Regensburg, , Germany
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, , Hungary
Dombóvári Szent Lukács Egészségügyi Kht.
Dombóvár, , Hungary
Petz Aladár Megyei Oktató Kórház
Győr, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, , Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
Miskolc, , Hungary
Pécsi Tudományegyetem
Pécs, , Hungary
Investigational Site
Szeged, , Hungary
Investigational Site
Acapulco, , Mexico
Hospital Christus Muguerza del Parque
Chihuahua, Chih., , Mexico
Investigational Sit
Durango, , Mexico
Hospital Aranda de la Parra , S.A. de C.V.
Leon, GTO, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
Mexico City, , Mexico
Investigational Site
Mexico City, , Mexico
Consultorio Medico
Zapopan, Jalisco, , Mexico
Investigational Site
Zapopan, Jalisco, , Mexico
Investigational Site
Ede, , Netherlands
Investigational Site
Eindhoven, , Netherlands
Atrium MC
Heerlen, , Netherlands
Hospital Andres Grillasca
Ponce, , Puerto Rico
Investigational Site
Arad, , Romania
Fundeni Uronephrology and Renal Transplant Clinical Institute
Bucharest, , Romania
Investigational Site
Bucharest, , Romania
Sfantul Ioan" Emergency Clinical Hospital
Bucharest, , Romania
PROVITA 2000 Medical Center
Constanța, , Romania
Investigational Site
Iași, , Romania
Sibiu Emergency Clinical County Hospital
Sibiu, , Romania
City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow, , Russia
City Clinical Hospital #60
Moscow, , Russia
Moscow State University of Medicine and Dentistry
Moscow, , Russia
City Pokrovskaya Hospital
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
Saint Petersburg, , Russia
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, , Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
Kharkiv, , Ukraine
Kyiv City Clinical Hospital #3
Kyiv, , Ukraine
Odesa State Medical University
Odesa, , Ukraine
Clatterbridge Centre For Oncology
Bebington, Wirral, , United Kingdom
Countries
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References
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Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Other Identifiers
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2006-006913-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FE200486 CS21A
Identifier Type: -
Identifier Source: org_study_id
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