Two drugs go Head-to-Head for easing enlarged prostate symptoms
NCT ID NCT01203371
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are comparing two drugs, naftopidil and tamsulosin, to see which better eases urinary symptoms in men with benign prostatic hyperplasia, a non-cancerous enlargement of the prostate. The study enrolls men aged 50 and older who have moderate to severe urinary symptoms, a prostate volume of at least 20 mL, and incomplete bladder emptying. Participants receive one of the two drugs for 12 weeks, and researchers track changes in symptom scores and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naftopidil and tamsulosin, two drugs that relax prostate and bladder muscles
- What this could lead to
- If naftopidil works as well as or better than tamsulosin, men with benign prostatic hyperplasia could have another option for easing urinary symptoms.
- What could go wrong
- This trial compares two existing drugs, so it is unlikely to produce a breakthrough. Both drugs can cause side effects such as dizziness or low blood pressure, and results may not apply to all men with BPH.
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 Hide 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.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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.