New combo pill approach aims to help men with Hard-to-Treat erectile dysfunction
NCT ID NCT07391579
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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21 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cairo University, faculty of medicine
RECRUITINGCairo, Egypt
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Faculty of Medicine - Assiut University
RECRUITINGAsyut, Egypt
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Faculty of medicine, Ain Shams University
RECRUITINGCairo, Egypt
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Faculty of medicine, Alexandria University
RECRUITINGAlexandria, Egypt
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Faculty of medicine, Aswan university
RECRUITINGAswān, Egypt
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Faculty of medicine, Azhar University
RECRUITINGCairo, Egypt
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Faculty of medicine, Luxor university
RECRUITINGLuxor, Egypt
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Faculty of medicine, Tanta University
RECRUITINGTanta, Egypt
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Faculty of medicine, october 6 Univeristy
RECRUITINGCairo, Egypt
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Urology and Nephrology Center, Mansoura University
RECRUITINGAl Mansurah, Dakahlia Governorate, Egypt
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faculty of medicine, Minya University
RECRUITINGMinya, Egypt
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Other studies related to the condition(s) this trial covers.
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- Can a Two-Pathway pill improve ED treatment? a new trial puts the combo to the test
- New urethral gel could help men with erectile dysfunction
- Ancient wisdom meets modern medicine: new study maps ED patterns
- Can acupuncture help men with pelvic pain and ED?
- Blood test may reveal hidden clues about erectile dysfunction