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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2001

Last Updated Date

January 12, 2010

Start Date ^ICMJE

December 1995

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00021814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Medical Therapy of Prostatic Symptoms (MTOPS)

Official Title ^ICMJE

Not Provided

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Prostatic Hyperplasia
Prostatic Hypertrophy, Benign

Intervention ^ICMJE

Drug: Doxazosin
Drug: Finasteride

Study Arm (s)

Not Provided

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

Enrollment ^ICMJE

2931

Completion Date

March 1998

Primary Completion Date

Not Provided

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.

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00021814

Other Study ID Numbers ^ICMJE

MTOPS (completed), U01-DK-46472

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

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.

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

January 2010

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

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