A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients
This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when
used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor
symptoms (hot flashes) following surgical or medical castration. All prostate cancer
therapy must be stable for at least 45 days before entering the study and must remain stable
throughout this 12-week study. To be eligible for this study prostate cancer patients must
have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH
agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must
have at least 21 moderate to severe hot flashes weekly.
Patients will maintain a daily paper diary to record the frequency and severity of hot
flashes during the treatment period. In addition, a brief physical evaluation will be done,
diaries will be reviewed and any adverse events will be recorded at each follow-up
evaluation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Throughout study
No
Duramed Protocol Chair
Study Chair
Duramed Research, Inc.
United States: Food and Drug Administration
DR-PCA-201
NCT00196339
June 2005
January 2008
Name | Location |
---|---|
Duramed Investigational Site | Birmingham, Alabama 35234 |
Duramed Investigational Site | Phoenix, Arizona 85013 |
Duramed Investigational Site | Little Rock, Arkansas 72211 |
Duramed Investigational Site | Anaheim, California 92801 |
Duramed Investigational Site | Denver, Colorado 80210 |
Duramed Investigational Site | Middlebury, Connecticut 06762 |
Duramed Investigational Site | Washington, District of Columbia 20307 |
Duramed Investigational Site | Aventura, Florida 33180 |
Duramed Investiational Site | Ocala, Florida 34474 |
Duramed Investigational site | Atlanta, Georgia 30342 |
Duramed Investigational Site | Coeur d'Alene, Idaho 83814 |
Duramed Investigational Site | Berwyn, Illinois 60402 |
Duramed Investigational Site | Greenwood, Indiana 46143 |
Duramed Investigational Site | Des Moines, Iowa 50309 |
Duramed Investigational Site | Overland Park, Kansas 66211 |
Duramed Investigational Site | New Orleans, Louisiana 70121 |
Duramed Investigational Site | Greenbelt, Maryland 20770 |
Duramed Investigational Site | Newton, Massachusetts 02462 |
Duramed Investigational Site | St. Joseph, Michigan 49085 |
Duramed Investigational Site | Sartell, Minnesota 56377 |
Duramed Investigational Site | Jackson, Mississippi 39202 |
Duramed Investigational Site | St. Louis, Missouri 63141 |
Duramed Investigational Site | Las Vegas, Nevada 89109 |
Duramed Investigational Site | Brick, New Jersey 08724 |
Duramed Investigational Site | Albany, New York 12208 |
Duramed Investigational Site | Asheboro, North Carolina 27203 |
Duramed Investigational Site | Fargo, North Dakota 58104 |
Duramed Investigational Site | Canfield, Ohio 44406 |
Duramed Investigational Site | Bethany, Oklahoma 73008 |
Duramed Investigational Site | Allentown, Pennsylvania 18103 |
Duramed Investigational Site | Providence, Rhode Island 02904 |
Duramed Investigational Site | Charleston, South Carolina 29425 |
Duramed Investigational Site | Knoxville, Tennessee 37920 |
Duramed Investigational Site | Austin, Texas 78705 |
Duramed Investigational Site | Salt Lake City, Utah 84124 |
Duramed Investigational Site | Richmond, Virginia 23235 |
Duramed Investigational Site | Seattle, Washington 98166 |
Duramed Investigational Site | Milwaukee, Wisconsin 53209 |