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Can a daily pill rescue erectile function when On-Demand treatments fail?

NCT ID NCT07753720

Disease control Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Sep 02, 2026 · Updated 9 times

Summary

This trial compares two approaches for men with erectile dysfunction that doesn't respond well to on-demand PDE5 inhibitor pills: taking a low-dose tadalafil pill every day on its own, or taking it alongside the usual on-demand medication. Over 12 weeks, researchers will measure changes in erectile function, treatment satisfaction, and side effects in 260 men aged 18 to 70. The goal is to see whether the daily-plus-on-demand combination offers better results than daily tadalafil alone.

What this could mean

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

Active substance
Tadalafil 5 mg taken daily, either alone or added to the participant's current on-demand PDE5 inhibitor
What this could lead to
If adding daily tadalafil works better than the on-demand pill alone, it could offer a new option for men whose erectile dysfunction doesn't improve with standard on-demand treatments.
What could go wrong
This is a relatively small, 12-week trial, and results may not apply to everyone. Tadalafil can cause side effects like headache, flushing, or upset stomach, and the added benefit over monotherapy is not guaranteed.

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

About 260 people

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

Started

Aug 2026

Expected to finish

Jun 2027

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 70 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 * Age: 18 to 70 years. * Diagnosis: Erectile dysfunction for at least 6 months. * PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as: * International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing. * Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts. * Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation. * Stable relationship: Sexually active with a female partner for at least 6 months. * Informed consent: Willing and able to provide written informed consent. Exclusion Criteria * Current use of nitrates. * Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure. * Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg. * Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m². * Untreated hypogonadism, total testosterone less than 250 ng/dL. * Severe penile anatomic deformity or prior penile prosthesis. * History of priapism. * Severe untreated depression. * Pelvic surgery or radiation within 6 months.

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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 Tadalafil

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

    RECRUITING

    Cairo, Egypt

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