Endothelial Markers and Tadalafil Response
NCT07773103 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120
Last updated 2026-08-20
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.
Conditions
- Vasculogenic Erectile Dysfunction
Interventions
- DRUG
-
Tadalafil 5mg
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
Sponsors & Collaborators
-
Al-Azhar University
lead OTHER
Principal Investigators
-
Abul-fotouh Ahmed · Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-19
- Primary Completion
- 2028-08-31
- Completion
- 2028-12-31
Countries
- Egypt
Study Locations
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