NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Endothelial Markers and Tadalafil Response

RecruitingN/A

Sponsor: Al-Azhar University

Conditions: Vasculogenic Erectile Dysfunction

Interventions: Tadalafil 5mg

Countries: Egypt

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 overview

Sex: MALE

Age: 30 Years to 70 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (1)

Cairo, Egypt