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RECRUITING
NCT07773103

Endothelial Markers and Tadalafil Response

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction

Key Details

Gender

MALE

Age Range

30 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-08-19

Completion Date

2028-12

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

Tadalafil 5mg

All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.

Locations (1)

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

Cairo, Egypt