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Clinical trialNCT00021814CompletedPhase 3Interventional

Medical Therapy of Prostatic Symptoms

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment3,407Prostatic HyperplasiaProstatic Hypertrophy, Benign
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California

    La Jolla, California, United States

  • Univ of Colorado Health Sciences Center

    Aurora, Colorado, United States

  • Yale University

    New Haven, Connecticut, United States

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, United States

  • Emory University

    Atlanta, Georgia, United States

  • Northwestern University

    Chicago, Illinois, United States

  • University of Iowa Hospitals Clinics

    Iowa City, Iowa, United States

  • University of Maryland

    Baltimore, Maryland, United States

  • Henry Ford Health Systems

    Detroit, Michigan, United States

  • Mayo Foundation

    Rochester, Minnesota, United States

  • Washington University

    St Louis, Missouri, United States

  • Columbia Presbyterian Medical Center

    New York, New York, United States

  • New York University School of Medicine

    New York, New York, United States

  • Vanderbilt University

    Nashville, Tennessee, United States

  • Ut Southwestern Medical Center

    Dallas, Texas, United States

  • Baylor College of Medicine

    Houston, Texas, United States

  • Brooke Army Medical Center

    San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Doxazosin →Doxazosin placeboFinasteride →Finasteride placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 1995
Primary completion
30 Nov 2001
Completion
30 Nov 2001
Last update posted
28 Sept 2018
Registered enrollment
3,407
Registry id
NCT00021814

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.