NCT00021814

Medical Therapy of Prostatic Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,407 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostatic Hyperplasia
• Prostatic Hypertrophy, Benign

Interventions

Type	Name	Description
DRUG	Doxazosin
DRUG	Finasteride
DRUG	Doxazosin placebo
DRUG	Finasteride placebo

Timeline

• Start date: 1995-12-01
• Primary completion: 2001-11-30
• Completion: 2001-11-30
• First posted: 2001-08-06
• Last updated: 2018-09-28

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study