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Medical Therapy of Prostatic Symptoms (MTOPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE August 4, 2001
First Posted Date  ICMJE August 6, 2001
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE December 1995
Actual Primary Completion Date November 30, 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Therapy of Prostatic Symptoms
Official Title  ICMJE Medical Therapy of Prostatic Symptoms
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatic Hyperplasia
  • Prostatic Hypertrophy, Benign
Intervention  ICMJE
  • Drug: Doxazosin
  • Drug: Finasteride
  • Drug: Doxazosin placebo
  • Drug: Finasteride placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Doxazosin and Finasteride placebos
    Interventions:
    • Drug: Doxazosin placebo
    • Drug: Finasteride placebo
  • Experimental: Doxazosin
    Doxazosin and Finasteride placebo
    Interventions:
    • Drug: Doxazosin
    • Drug: Finasteride placebo
  • Experimental: Finasteride
    Doxazosin placebo and Finasteride
    Interventions:
    • Drug: Finasteride
    • Drug: Doxazosin placebo
  • Experimental: Combination
    Doxazosin and Finasteride
    Interventions:
    • Drug: Doxazosin
    • Drug: Doxazosin placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
3407
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
2931
Actual Study Completion Date  ICMJE November 30, 2001
Actual Primary Completion Date November 30, 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00021814
Other Study ID Numbers  ICMJE MTOPS (completed)
U01DK046472 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data and specimens will be submitted to the NIDDK Central Repository
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2006
URL: https://repository.niddk.nih.gov/studies/mtops/?query=mtops
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE George Washington University
Investigators  ICMJE
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.
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date September 2018

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