The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
NCT ID: NCT00295750
Last Updated: 2012-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
620 participants
INTERVENTIONAL
2006-02-28
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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degarelix 240/160 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
degarelix 240/80 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Interventions
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Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline testosterone \>1.5 ng/mL.
* Life expectancy of at least 12 months.
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
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Advanced Urology Medical Center
Anaheim, California, United States
Pacific Clinical Center
Beverly Hills, California, United States
Simi-San Faernando Valley Urology Associates
Granada Hills, California, United States
South Orange County Medical Research Center
Laguna Woods, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associate PC
Denver, Colorado, United States
University of Colorado
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Florida Foundation for Healthcare Research
Ocala, Florida, United States
Regional Urology
Shreveport, Louisiana, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Jay A. Motola, MD, FACS
Carmel, New York, United States
Northeast Urology Research
Concord, North Carolina, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
Univeristy Urological Research Institute
Providence, Rhode Island, United States
University Urological Research Institute
Providence, Rhode Island, United States
Grand Strand Urology
Myrtle Beach, South Carolina, United States
Urology San Antonio Research
San Antonio, Texas, United States
Urology of Virginia Research
Norfolk, Virginia, United States
Office of Jeffrey Frankel
Seattle, Washington, United States
Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
Kentville, Nova Scotia, Canada
Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
Jindřichův Hradec, , Czechia
Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
Mannheim, , Germany
Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
Szeged, , Hungary
Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
Predio Canoas S/N, Durango, DGO, Mexico
Atrium MC, Henri Dunantstraat 5
Heerlen, , Netherlands
Cristo Redentor Hospital
La Hacienda, , Puerto Rico
San Juan VA Medical Center
San Juan, , Puerto Rico
Provita Center, 2 Primaverii Street
Constanța, , Romania
Andros Urology Clinic, Ulitsa Lenina 36A
Saint Petersburg, , Russia
Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
Kiev, , Ukraine
Derriford Hospital, Derriford Road
Plymouth, , United Kingdom
Countries
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References
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Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
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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FE200486 CS21
Identifier Type: -
Identifier Source: org_study_id