Cure My Disease

Don't miss your cure!

 Log in / Sign up

PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA

NCT ID NCT01203371

NEW Sponsor: Apsen Farmaceutica S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Started

Jan 2011

Finished

Jan 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men ≥ 50 years * Signs and symptoms of BPH * IPSS of ≥ 10 * Prostate volume of ≥ 20 mL * PVR \> 150 mL Exclusion Criteria: * History of allergy to a AR antagonists * Treatment with antiandrogen drugs * Drugs with anticholinergic activity * Significant history of orthostatic hypotension * Concomitant neurological diseases * Known or suspected neurogenic bladder dysfunction * Carcinoma of the prostate or bladder * Previous surgery for BPH or bladder neck obstruction * History of recurrent UTI * Concomitant active UTI

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hyperplasia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperplasia

Contacts and locations

Locations

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-010, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.