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Could two ED pills be better than one? new trial investigates

NCT ID NCT07177326

Symptom relief Sponsor: Assiut University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 study tests whether taking a low dose of two different erectile dysfunction drugs (tadalafil 2.5 mg plus sildenafil 25 mg) daily works better than taking a standard dose of just one (tadalafil 5 mg). The trial will involve 142 men aged 18 to 70 with ED for at least 3 months. Each participant will try both treatments in a random order, without knowing which they are taking, to compare effectiveness and safety.

What this could mean

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

Active substance
tadalafil and sildenafil (two different PDE5 inhibitor drugs)
What this could lead to
If it works, this could offer a more effective daily option for men with erectile dysfunction who don't respond well to single-drug therapy.
What could go wrong
This is a small Phase 3 trial (142 men) and the combination may not prove significantly better than the standard dose. Side effects like headache or flushing could increase with two drugs.

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 142 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 60 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 aged 18-70 years with a clinical diagnosis of erectile dysfunction (ED) for ≥3 months. * International Index of Erectile Function (IIEF-5) score ≤21. * Stable sexual relationship for ≥3 months. * Willingness to adhere to the study protocol and provide informed consent. * No prior use of PDE5 inhibitors within 4 weeks before enrollment. Exclusion Criteria: * -Severe cardiovascular disease (uncontrolled hypertension, recent MI/stroke). * Hypersensitivity to tadalafil, sildenafil, or any PDE5 inhibitor. * Severe hepatic/renal impairment (e.g., CrCl \<30 mL/min, Child-Pugh C). * Concomitant use of nitrates, strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole). * History of priapism, penile deformities, or radical prostatectomy. * Major psychiatric disorders affecting compliance.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

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

Erectile dysfunction

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.