Endothelial Markers and Tadalafil Response

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-70
SponsorAl-Azhar University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tadalafil 5mg

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators