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New combo pill aims to restore sexual function in men with prostate trouble

NCT ID NCT04185441

Symptom relief Sponsor: EMS 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called Tanzânia in 295 men who have both erectile dysfunction and an enlarged prostate (benign prostatic hyperplasia). The goal was to see if the drug improves erectile function better than a placebo. Participants took the drug or a dummy pill for a period, and researchers measured changes in a standard erectile function questionnaire. The study also tracked any side effects.

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

295 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2024

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

18 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: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Male participants aged 18 years or more; * Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month; * Diagnosis of Benign Prostatic Hyperplasia; * Diagnosis of erectile dysfunction; * Patients with score between 6 and 25 points in the erectile function questionnaire; * IPSS (International Prostate Symptom Score) greater or equal to 8 points; Exclusion Criteria: * Known hypersensitivity to the formula components used during the clinical trial; * History of alcohol and/or substance abuse within 2 years; * Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis; * Clinical evidence of prostate cancer; * Hypogonadism or absent sexual desire; * Severe psychiatric or psychosocial disorders; * Primary erectile dysfunction; * Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections; * Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia erectile dysfunction

As listed by the trial registrant

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

Benign prostatic hyperplasia Erectile dysfunction

Contacts and locations

Locations

  • Allergisa

    Campinas, São Paulo, Brazil

More trials for these conditions

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