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Endothelial Markers and Tadalafil Response

ConditionVasculogenic Erectile Dysfunction
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

This trial does not accept healthy volunteers

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 population

Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tadalafil 5mg

    Drug

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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Tadalafil 5 mg once daily1 intervention

Trial outcomes

Primary outcomes

1

Clinical response to tadalafil at 12 weeks

Proportion of participants achieving clinical response, defined as an increase of at least 4 points in the IIEF-EF domain score from baseline together with a positive response to the Global Assessment Question. The IIEF-EF domain scores erectile function on a higher-is-better scale; higher scores indicate better erectile function.

Time frame
12 weeks

Secondary outcomes

1

Change in the International Index of Erectile Function erectile function score.

Change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF). The IIEF-EF domain is a validated erectile function score, with higher values indicating better erectile function.

Time frame
Baseline to 12 weeks
2

Change in Erection Hardness Score

Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection. Higher scores indicate firmer erections.

Time frame
Baseline and12 weeks.
3

Brachial artery flow-mediated dilatation

Association between baseline brachial artery flow-mediated dilatation percentage and clinical response to tadalafil. Flow-mediated dilatation is a functional ultrasound-based measure of endothelial-dependent vasodilation; lower values indicate worse endothelial function. Baseline FMD will be evaluated as an independent predictor of treatment response.

Time frame
Baseline
4

Carotid intima-media thickness

Association between baseline mean carotid intima-media thickness and clinical response to tadalafil. Carotid intima-media thickness is a structural ultrasound marker of subclinical atherosclerosis; higher values indicate more advanced vascular wall thickening. Baseline CIMT will be evaluated as an independent predictor of treatment response.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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