Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
NCT ID: NCT00468286
Last Updated: 2011-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2007-05-31
2008-08-31
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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A
Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Degarelix
Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Degarelix
Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
B
Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Degarelix
Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Interventions
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Degarelix
Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Degarelix
Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Eligibility Criteria
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Exclusion Criteria
* Screening testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL.
* Eastern Cooperative Oncology Group (ECOG) score of ≤2.
* Screening prostate-specific antigen (PSA) level ≥ ng/mL.
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
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 Woods, California, 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
Investigational site
Carmel, New York, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
Grand Strand Urology
Myrtle Beach, South Carolina, United States
Urology of Virginia Research
Norfolk, Virginia, United States
Urology Research Center
Seattle, Washington, United States
Investigational site
Surrey, British Columbia, Canada
Investigational site
Victoria, British Columbia, Canada
Investigational site
Kentville, Nova Scotia, Canada
The Female/Male Health Centres
Ontario, , Canada
Nemocnice Jindrichuv Hradec a.s.
Hradec, , Czechia
Slezska nemocnice
Opava, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Dombóvári Szent Lukács Egészségügyi Kht
Dombóvár, , Hungary
Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, , Hungary
Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
Miskolc, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
Private Medical Center
Arad, , Romania
"Prof Dr Th Burghele" Clinical Hospital
Bucharest, , Romania
Dinu Uromedica
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
E-Uro Medical Center S.R.L.
Cluj-Napoca, , Romania
Provita Center
Constanța, , Romania
Sibiu County Clinical Hospital
Sibiu, , Romania
Countries
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Other Identifiers
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FE200486 CS18
Identifier Type: -
Identifier Source: org_study_id
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