Spots Global Cancer Trial Database for Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
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Trial Identification
Brief Title: Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Official Title: Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
Study ID: NCT00056654
Conditions
Interventions
Study Description
Brief Summary: The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
Detailed Description: The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Centers of Alabama, Homewood, Alabama, United States
Medical Affiliated Research Center, Huntsville, Alabama, United States
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
Arkansas Urology, Little Rock, Arkansas, United States
Pacific Clinical Center, Encino, California, United States
Los Angeles Clinical Research Center, Encino, California, United States
Urology Associates of Central California, Fresno, California, United States
Center for Urologic Research, La Mesa, California, United States
South Orange County Medical Research Center, Laguna Woods, California, United States
San Diego Uro-Research, San Diego, California, United States
Western Clinical Research, Torrance, California, United States
Urology Research Options, Aurora, Colorado, United States
Connecticut Clinical Research Center, Waterbury, Connecticut, United States
South Florida Medical Research, Aventura, Florida, United States
Atlantic Urological Associates, Daytona Beach, Florida, United States
UroSearch, Inverness, Florida, United States
Advanced Research Institute, New Port Richey, Florida, United States
Atlantic Urological Associates, New Smyrna Beach, Florida, United States
UroSearch, Ocala, Florida, United States
Florida Foundation for Healthcare Research, Ocala, Florida, United States
Atlantic Urological Associates, Orange City, Florida, United States
Atlantic Urological Associates, St. Augustine, Florida, United States
Emory University, Atlanta, Georgia, United States
Georgia Urology, PA, Atlanta, Georgia, United States
West Side Veteran Administration Medical Center, Chicago, Illinois, United States
Kankakee Urological Associates, Kankakee, Illinois, United States
Specialty Care Research, Peoria, Illinois, United States
Welborn Clinic East, Evansville, Indiana, United States
Northeast Indiana Research, Fort Wayne, Indiana, United States
Urology of Indiana, LLC, Indianapolis, Indiana, United States
Urological Associates, PC, Davenport, Iowa, United States
206 Research Associates, Greenbelt, Maryland, United States
Lawrenceville Urology, St Joseph, Michigan, United States
Kansas City Urology Care, Kansas City, Missouri, United States
Saint Louis Urological Surgeons, Inc, St Louis, Missouri, United States
Sheldon J. Freedman, MD, LTD, Las Vegas, Nevada, United States
Nevada Urology Associates, Reno, Nevada, United States
Urological Surgical Associates, Edison, New Jersey, United States
Lawrenceville Urology, Lawrenceville, New Jersey, United States
Associated Urologic Specialists, PA, Marlton, New Jersey, United States
Suffolk Urology Associates, Bay Shore, New York, United States
Urological Surgeons of Long Island, Garden City, New York, United States
Hudson Valley Urology, Poughkeepsie, New York, United States
Center for Urologic Research of Western New York, Williamsville, New York, United States
Northeast Urology Research, Concord, North Carolina, United States
The Urology Group, Cincinnati, Ohio, United States
University Urological Research Institute, Providence, Rhode Island, United States
Grand Strand Urology, Myrtle Beach, South Carolina, United States
Vanderbilt Medical Center Dept of Urologic Surgery, Nashville, Tennessee, United States
Urology Specialists & Associates, Dallas, Texas, United States
Urology Associates of North Texas, Fort Worth, Texas, United States
Urology San Antonio Research, San Antonio, Texas, United States
Salt Lake Research, Salt Lake City, Utah, United States
Devine-Tidewater Urology, Virginia Beach, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
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