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Can adjusting drug schedules improve both urinary and sexual outcomes in men with enlarged prostate?

NCT ID NCT07715448

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This clinical trial investigates whether different dosing schedules of tadalafil or tamsulosin, when combined with a 5-alpha reductase inhibitor, can better manage urinary symptoms and preserve sexual function in men with benign prostatic hyperplasia (BPH). The study includes 240 men aged 50 and older with moderate to severe symptoms and an enlarged prostate. Over 12 weeks, researchers will measure changes in urinary symptoms, erectile function, and ejaculatory function to find the optimal combination regimen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tadalafil or tamsulosin combined with a 5-alpha reductase inhibitor (finasteride or dutasteride)
What this could lead to
If successful, this could identify the most effective dosing regimen to improve both urinary symptoms and sexual function in men with an enlarged prostate.
What could go wrong
This is a single-blind, 12-week study with 240 participants, so results may not apply to all men or longer-term use. Side effects from these drugs can include dizziness, low blood pressure, and sexual 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

240 people

The number who actually took part.

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 or older. * Newly diagnosed with benign prostatic hyperplasia (BPH). * Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) \> 7. * Prostate volume \>40 mL confirmed by transrectal ultrasonography (TRUS). * Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score \>10. * Prostate-specific antigen (PSA) \<4 ng/mL and no suspicious findings on digital rectal examination (DRE). * Able and willing to provide written informed consent. Exclusion Criteria: * History of prostate cancer. * Previous prostate surgery. * Abnormal digital rectal examination suggestive of malignancy. * Severe erectile dysfunction (IIEF-EF score ≤10). * Uncontrolled diabetes mellitus. * Uncontrolled cardiovascular disease. * Neurological disorders affecting bladder function. * Renal impairment. * Hepatic impairment. * Active urinary tract infection. * Bladder stones or other significant urological pathology. * Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors. * Patients actively seeking fertility treatment. * Current use of medications known to significantly affect sexual function. * Concurrent use of nitrates or contraindicated antihypertensive medications.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Ejaculatory Dysfunction erectile dysfunction Lower Urinary Tract Symptoms

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beni-Suef University Hospital

    Banī Suwayf, Beni Suef Governorate, Egypt

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