Blood markers may forecast ED treatment success
NCT ID NCT07773103
First seen Aug 19, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests whether certain blood markers can predict how well men with vasculogenic erectile dysfunction (ED) respond to a daily 5 mg dose of tadalafil. About 120 men aged 30-70 will take tadalafil for 12 weeks, and researchers will measure erectile function along with levels of several biomarkers linked to blood vessel health. The goal is to see if these markers can identify who is most likely to benefit from the treatment, potentially allowing for more personalized care.
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 orally once daily for 12 weeks
- What this could lead to
- If certain blood markers predict who benefits from tadalafil, doctors could personalize ED treatment, saving time and improving outcomes.
- What could go wrong
- This is a single-group study without a placebo, so results may not prove tadalafil's effect. The marker-based prediction may not hold up in broader populations.
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.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2028
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.
Who is studied
Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.
- Ages
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30 to 70 years
- 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: * Participants must fulfill all of the following: * Men aged 30 to 70 years. * ED lasting at least 3 months. * IIEF-5/SHIM score of 21 or less or clinically documented ED. * Clinical features suggesting predominantly vasculogenic ED. * Sexually active or willing to attempt sexual intercourse during the study. * Able to complete the study questionnaires. * Willing to take tadalafil 5 mg once daily for 12 weeks. * Able to provide written informed consent. * Willing to avoid other ED treatments during the study unless medically necessary. Exclusion Criteria: * Patients will be excluded if they have: * ED primarily attributed to psychogenic causes. * Predominantly neurogenic ED. * Severe untreated hypogonadism likely to be the primary cause of ED. * Untreated hyperprolactinemia or another major endocrine disorder. * Significant penile anatomical abnormality interfering with intercourse, including severe Peyronie's disease. * Previous radical pelvic surgery or pelvic radiotherapy. * Active urinary or genital infection. * Unstable angina or unstable cardiovascular disease. * Recent myocardial infarction or stroke. * Uncontrolled hypertension or clinically significant hypotension. * Severe renal impairment requiring an alternative tadalafil regimen. * Severe hepatic impairment. * Active malignancy or expected survival of less than one year. * Major psychiatric illness, cognitive impairment or inability to comply with follow-up. * Current use of another PDE5 inhibitor or intracavernosal therapy that cannot be discontinued. * Concomitant use of organic nitrates, nitric oxide donors or nicorandil. * Known hypersensitivity to tadalafil. * Participation in another study that may affect erectile function or vascular measurements. * Refusal or inability to provide informed consent.
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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
1 site. 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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Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
RECRUITINGCairo, Egypt
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