Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
NCT ID: NCT00117286
Last Updated: 2025-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
57 participants
INTERVENTIONAL
2005-03-31
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.
Detailed Description
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The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix (60 mg to 160 mg)
Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
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 (80 mg to 160 mg)
Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
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
* Has completed study FE200486 CS14 through visit 22.
Exclusion Criterion:
* Has been withdrawn from the FE200486 CS14 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
Advanced Urology Medical Center
Anaheim, California, United States
West Coast Clinical Research
Tarzana, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associate PC'
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
SW Florida Urological Associates
Fort Myers, Florida, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Regional Urology
Shreveport, Louisiana, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
University Urological Research Institute
Providence, Rhode Island, United States
Urology San Antonio Research
San Antonio, Texas, United States
University of Vermont, Dept of Surgery
South Burlington, Vermont, United States
Virginia Urology Center
Richmond, Virginia, United States
Investigational site
Seattle, Washington, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
The Male and Female Health and Research Centers
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
Burlington Professional Care
Burlington, Ontario, Canada
The Female/Male Health Centres
Oakville, Ontario, Canada
Countries
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Other Identifiers
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FE200486 CS14A
Identifier Type: -
Identifier Source: org_study_id