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Medical Therapy of Prostatic Symptoms (MTOPS)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00021814
First received: August 4, 2001
Last updated: January 12, 2010
Last verified: January 2010

August 4, 2001
January 12, 2010
December 1995
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Complete list of historical versions of study NCT00021814 on ClinicalTrials.gov Archive Site
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Medical Therapy of Prostatic Symptoms (MTOPS)
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Prostatic Hyperplasia
  • Prostatic Hypertrophy, Benign
  • Drug: Doxazosin
  • Drug: Finasteride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2931
March 1998
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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.
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00021814
MTOPS (completed), U01-DK-46472
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP