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Medical Therapy of Prostatic Symptoms (MTOPS)

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ClinicalTrials.gov Identifier: NCT00021814
Recruitment Status : Completed
First Posted : August 6, 2001
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
George Washington University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Prostatic Hypertrophy, Benign Drug: Doxazosin Drug: Finasteride Drug: Doxazosin placebo Drug: Finasteride placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Therapy of Prostatic Symptoms
Actual Study Start Date : December 1995
Actual Primary Completion Date : November 30, 2001
Actual Study Completion Date : November 30, 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Doxazosin and Finasteride placebos
Drug: Doxazosin placebo
Drug: Finasteride placebo
Experimental: Doxazosin
Doxazosin and Finasteride placebo
Drug: Doxazosin
Drug: Finasteride placebo
Experimental: Finasteride
Doxazosin placebo and Finasteride
Drug: Finasteride
Drug: Doxazosin placebo
Experimental: Combination
Doxazosin and Finasteride
Drug: Doxazosin
Drug: Doxazosin placebo




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021814


Locations
United States, California
University of California
La Jolla, California, United States, 92093-0694
United States, Colorado
Univ of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010-0510
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63141
United States, New York
New York University School of Medicine
New York, New York, United States, 10010
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2765
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 5235-9110
Baylor College of Medicine
Houston, Texas, United States, 77005
Brooke Army Medical Center
San Antonio, Texas, United States, 78234-6200
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
George Washington University
Investigators
Principal Investigator: E. David Crawford Clinic 01 - Univ of Colorado Health Sciences Center
Principal Investigator: Steven A. Kaplan Clinic 02 - New York Presbyterian Hospital
Principal Investigator: Claus Roehrborn Clinic 03 - UT Southwestern Medical Center
Principal Investigator: Noah S. Schenkman Clinic 04 - Walter Reed Army Medical Center
Principal Investigator: Herbert Lepor Clinic 06 - New York University School of Medicine
Principal Investigator: Kevin M. Slawin Clinic 07 - Baylor College of Medicine
Principal Investigator: John P. Foley Clinic 08 - Brooke Army Medical Center
Principal Investigator: Joe W. Ramsdell Clinic 09 - University of California San Diego
Principal Investigator: Mani Menon Clinic 10 - Henry Ford Hospital
Principal Investigator: Michael M. Lieber Clinic 11 - Mayo Foundation
Principal Investigator: Kevin T. McVary Clinic 12 - Northwestern University
Principal Investigator: Joseph A. Smith Clinic 13 - Vanderbilt University
Principal Investigator: Gerald L. Andriole Clinic 14 - Washington University
Principal Investigator: Harris E. Foster Clinic 15 - Yale University
Principal Investigator: Harry S. Clarke Clinic 16 - Emory University
Principal Investigator: Karl J. Kreder Clinic 17 - University of Iowa
Principal Investigator: Stephen C. Jacobs Clinic 18 - University of Maryland
Principal Investigator: Gary J. Miller Diagnostic Center - Univ of Colorado Health Sciences Center
Principal Investigator: Oliver M. Bautista Biostatistical Coordinating Center - George Washington Univ.

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00021814     History of Changes
Other Study ID Numbers: MTOPS (completed)
U01DK046472 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2001    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and specimens will be submitted to the NIDDK Central Repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 2006
URL: https://repository.niddk.nih.gov/studies/mtops/?query=mtops

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
BPH progression
Medical Therapy
Finasteride
Doxazosin
Randomized
Multi-center
Clinical Trial
Proscar
Cardura

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Finasteride
Doxazosin
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents