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Endothelial Markers and Tadalafil Response

19 augustus 2026 bijgewerkt door: Abul-fotouh Ahmed, Al-Azhar University

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Erectile dysfunction is a common male sexual disorder and is often associated with endothelial dysfunction, impaired nitric oxide bioavailability, inflammation, arterial stiffness, and subclinical atherosclerosis. Because penile arteries are relatively small, vasculogenic erectile dysfunction may appear before overt cardiovascular disease. Brachial artery flow-mediated dilatation reflects endothelial-dependent vasodilation, carotid intima-media thickness reflects structural vascular change, and circulating endothelial biomarkers may provide additional information about endothelial injury and inflammation.

This prospective observational cohort study will recruit men with predominantly vasculogenic erectile dysfunction attending the Urology/Andrology outpatient clinic. Baseline demographic, clinical, sexual, laboratory, vascular, and biomarker data will be collected before treatment. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function will be measured again at follow-up using the IIEF-EF domain, IIEF-5/SHIM, and the Global Assessment Question. The primary outcome is clinical response at 12 weeks, defined as an improvement of at least 4 points in IIEF-EF together with a positive Global Assessment Question response. The study will also evaluate whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.

Studietype

Observationeel

Inschrijving (Geschat)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
      • Cairo, Egypte
        • Werving
        • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Tadalafil 5 mg once daily
Adult men with predominantly vasculogenic erectile dysfunction who are eligible for tadalafil 5 mg once daily and enrolled in this prospective cohort study.
Geneesmiddel: Tadalafil 5mg
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
Andere namen:
  • PDE5-remmer

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical response to tadalafil at 12 weeks
Tijdsspanne: 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.
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the International Index of Erectile Function erectile function score.
Tijdsspanne: Baseline to 12 weeks
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.
Baseline to 12 weeks
Change in Erection Hardness Score
Tijdsspanne: Baseline and12 weeks.
Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection. Higher scores indicate firmer erections.
Baseline and12 weeks.
Brachial artery flow-mediated dilatation
Tijdsspanne: Baseline
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.
Baseline
Carotid intima-media thickness
Tijdsspanne: Baseline
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.
Baseline
Serum endothelin-1 level
Tijdsspanne: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum nitrite/nitrate level
Tijdsspanne: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum high-sensitivity C-reactive protein
Tijdsspanne: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Adverse events during tadalafil treatment
Tijdsspanne: Throughout the 12-week treatment period.
Number and type of treatment-emergent adverse events occurring during 12 weeks of tadalafil 5 mg once-daily therapy.
Throughout the 12-week treatment period.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Al-Azhar University

Onderzoekers

  • Hoofdonderzoeker: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 augustus 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

16 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2026

Eerst geplaatst (Werkelijk)

19 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UroAzhar_18_026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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