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Recruiting NCT07773103

Endothelial Markers and Tadalafil Response

Conditions: Vasculogenic Erectile Dysfunction

Sex: Male
Ages: 30 Years – 70 Years
Healthy volunteers: No
Enrollment: 120
Sponsor: Al-Azhar University

Location: Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University Cairo

Summary

This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic. Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation, carotid intima-media thickness, and selected circulating endothelial biomarkers including endothelin-1, nitrite/nitrate, high-sensitivity C-reactive protein, soluble vascular cell adhesion molecule-1, and soluble intercellular adhesion molecule-1. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function, adherence, and adverse events will be assessed during follow-up. The primary outcome will be clinical response at 12 weeks, defined as an improvement of at least 4 points in the IIEF-EF domain together with a positive response to the Global Assessment Question.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07773103). StuddyBuddy aggregates publicly available trial information.