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New combo pill approach aims to help men with Hard-to-Treat erectile dysfunction

NCT ID NCT07391579

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking a daily low-dose tadalafil plus an on-demand higher-dose sildenafil works better than on-demand sildenafil alone for men with erectile dysfunction who haven't responded to standard treatments. About 500 men will take the combo or a placebo for 12 weeks, and researchers will measure changes in erectile function and hardness scores. The goal is to find a safe, effective option for those who currently have few alternatives.

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
What this could lead to
If it works, this could offer a new treatment option for men with erectile dysfunction who do not respond to standard pills alone.
What could go wrong
This is a Phase 4 trial, but it only lasts 12 weeks and focuses on a specific group of non-responders. The combination may not work for everyone and could cause side effects like headache or flushing.

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 500 people

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

Started

Dec 2025

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

21 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: * Sexually active male. * History of ED for ≥6 months. * Erectile function domain of IIEF-15 score \<17. * Documented failure to respond to PDE-5I \[definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4 occasions in spite of accurate timing and good sexual stimulation\]. * Stable sexual relationship ≥ 6 months. Exclusion Criteria: * Penile anatomical deformities or Peyronie's disease. * Pelvic surgery or radiation. * Active malignancy or severe systemic illness. * Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting. * Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension). * Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    11 sites. 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

  • Cairo University, faculty of medicine

    RECRUITING

    Cairo, Egypt

  • Faculty of Medicine - Assiut University

    RECRUITING

    Asyut, Egypt

  • Faculty of medicine, Ain Shams University

    RECRUITING

    Cairo, Egypt

  • Faculty of medicine, Alexandria University

    RECRUITING

    Alexandria, Egypt

  • Faculty of medicine, Aswan university

    RECRUITING

    Aswān, Egypt

  • Faculty of medicine, Azhar University

    RECRUITING

    Cairo, Egypt

  • Faculty of medicine, Luxor university

    RECRUITING

    Luxor, Egypt

  • Faculty of medicine, Tanta University

    RECRUITING

    Tanta, Egypt

  • Faculty of medicine, october 6 Univeristy

    RECRUITING

    Cairo, Egypt

  • Urology and Nephrology Center, Mansoura University

    RECRUITING

    Al Mansurah, Dakahlia Governorate, Egypt

  • faculty of medicine, Minya University

    RECRUITING

    Minya, Egypt

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