Medical Therapy of Prostatic Symptoms
- Conditions
- Prostatic HyperplasiaProstatic Hypertrophy, Benign
- Interventions
- Registration Number
- NCT00021814
- Brief Summary
The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).
MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3407
- Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml.
- American Urological Association Symptom Score is greater than or equal to 8 and less than or equal to 30.
- Voluntarily signed the informed consent agreement prior to the performance of any study procedures.
- Serum prostate specific antigen level greater than 10 ng/ml.
- Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension.
- Any prior medical or surgical intervention for BPH.
- Received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Finasteride placebo Doxazosin and Finasteride placebos Doxazosin Finasteride placebo Doxazosin and Finasteride placebo Combination Doxazosin placebo Doxazosin and Finasteride Finasteride Doxazosin placebo Doxazosin placebo and Finasteride Placebo Doxazosin placebo Doxazosin and Finasteride placebos Finasteride Finasteride Doxazosin placebo and Finasteride Doxazosin Doxazosin Doxazosin and Finasteride placebo Combination Doxazosin Doxazosin and Finasteride
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
University of California
🇺🇸La Jolla, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Iowa Hospitals Clinics
🇺🇸Iowa City, Iowa, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Univ of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Mayo Foundation
🇺🇸Rochester, Minnesota, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States