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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00468286 |
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Degarelix |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Degarelix Powder and Solvent for Suspension for Injection |
Enrollment: | 134 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
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.
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Drug: 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.
Drug: 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: Experimental
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.
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Drug: 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. |
An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion / Exclusion Criteria:
Primary endpoint:
- Probability of testosterone at castration level (≤05., ng/mL) from Day 28 through Day 364.
Secondary endpoints:
United States, Alabama | |
Medical Affiliated Research Center | |
Huntsville, Alabama, United States, 35801 | |
Urology Centers of Alabama | |
Homewood, Alabama, United States, 35209 | |
United States, California | |
South Orange County Medical Research Center | |
Laguna Woods, California, United States, 92653 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
South Florida Medical Research | |
Aventura, Florida, United States, 33180 | |
Florida Foundation for Healthcare Research | |
Ocala, Florida, United States, 34474 | |
United States, Louisiana | |
Regional Urology | |
Shreveport, Louisiana, United States, 71106 | |
United States, New Jersey | |
Lawrenceville Urology | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, New York | |
Jay A. Motola, MD, FACS | |
Carmel, New York, United States, 10512 | |
United States, North Carolina | |
The Urology Center | |
Greensboro, North Carolina, United States, 27403 | |
North Urology Research | |
Concord, North Carolina, United States, 28025 | |
United States, Pennsylvania | |
State College Urologic Association | |
State College, Pennsylvania, United States, 16801 | |
United States, South Carolina | |
Grand Strand Urology | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Virginia | |
Urology of Virginia Research | |
Norfolk, Virginia, United States, 23502 | |
United States, Washington | |
Office of Jeffrey Frankel | |
Seattle, Washington, United States, 98166 |
Study Director: | Weiying Gong, MD & MS | Ferring Pharmaceutical Inc. |
Study ID Numbers: | FE 200486 CS18 |
Study First Received: | April 13, 2007 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00468286 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer. |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |