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New pill aims to calm enlarged prostate woes

NCT ID NCT07270432

Symptom relief Sponsor: Ache Laboratorios Farmaceuticos 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine, DNN.65.21.005, against a standard drug (Combodart) to see if it safely reduces urinary problems caused by an enlarged prostate. About 218 men aged 50 and older with bothersome symptoms will take the drug for 180 days. The main goal is to measure changes in symptom scores from the start to the end of treatment.

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.

Participants

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

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 years and older

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: * Male participants aged 50 years and older. * Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF). * Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes. Exclusion Criteria: * History or evidence of prostate cancer. * Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound. * Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder. * Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit. * Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment. * Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment. * Use of any prohibited medications within the timeframe specified in the study protocol. * Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

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

Prostatic hyperplasia, benign

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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