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NCT00021814 · ClinicalTrials.gov registry record · Phase 3

Medical Therapy of Prostatic Symptoms

A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 3
Development phase
3,407
Enrollment target

NCT00021814: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00021814 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 3,407 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (341% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00021814, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 3
Development phase
3,407 participants
Enrollment target

Study 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.

Interventions

  • DRUG Doxazosin
  • DRUG Finasteride
  • DRUG Doxazosin placebo
  • DRUG Finasteride placebo

Trial Details

FieldValue
Enrollment Target 3,407 participants
Start Date 1995-12
Est. Completion 2001-11-30
Phase Phase 3

What the finished NCT00021814 record still lists

NCT00021814 is an interventional study that assigns participants to a tested intervention. Its 3,407 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (341% higher).

The record links to 0 conditions, and to 4 interventions - of which Doxazosin is the first listed.

NCT00021814 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00021814 about?

NCT00021814 is a clinical study titled "Medical Therapy of Prostatic Symptoms". 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 ...

What is the current status of trial NCT00021814?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,407 participants. The study started on 1995-12. Estimated completion is 2001-11-30.

What interventions are being tested in trial NCT00021814?

The interventions under investigation include: Doxazosin (DRUG), Finasteride (DRUG), Doxazosin placebo (DRUG), Finasteride placebo (DRUG).

Who is sponsoring clinical trial NCT00021814?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00021814's enrollment target sits among peer trials

3,407 70th of 2000 higher than 1,931 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00021814, the US trial registry maintained by the National Library of Medicine. NCT00021814 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.