CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,407 enrolled
Drug / intervention
Doxazosin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00021814
NCT00021814Phase 3Completed

Medical Therapy of Prostatic Symptoms

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Aug 6, 2001·Updated Sep 28, 2018

In Brief

A Phase 3 clinical trial evaluating Doxazosin, Finasteride, and 2 other interventions for Prostatic Hyperplasia and Prostatic Hypertrophy, Benign. Completed, enrolled 3,407 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2001
Enrollment StartDec 1, 1995
Primary CompletionNov 30, 2001
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 24.9 years ago

Interventions

Doxazosindrug

Finasteridedrug

Doxazosin placebodrug

Finasteride placebodrug