Endothelial Markers and Tadalafil Response in Vasculogenic Erectile Dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort will enroll men with predominantly vasculogenic erectile dysfunction seen in a urology outpatient clinic. Baseline assessments will include demographic data, cardiovascular risk factors, erectile function questionnaires, basic labs, vascular tests (brachial flow-mediated dilation and carotid intima-media thickness), and circulating endothelial biomarkers. All participants will take tadalafil 5 mg once daily for 12 weeks, with follow-up assessments of erectile function, adherence, and adverse events. The primary outcome is a clinical response at 12 weeks, defined as at least a 4-point improvement in the IIEF-EF domain and a positive Global Assessment Question. The study also examines whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Abul-fotouh Ahmed — Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
• Study coordinator: Abul-fotouh Ahmed
• Email: abulfotouhahmed@yahoo.com
• Phone: +201001066756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.