Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
NCT ID: NCT00056654
Last Updated: 2008-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
164 participants
INTERVENTIONAL
2003-03-31
2004-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Need for androgen deprivation treatment for 1 year
* Serum testosterone level ≥ 150 ng/dL
* Life expectancy of at least 18 months
* ECOG Performance status grades 0,1 or 2
Exclusion Criteria
* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
* History of hypogonadism
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abbott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Saint 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
Saint 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C02-008
Identifier Type: -
Identifier Source: org_study_id