Endothelial Markers and Tadalafil Response
Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Abul-fotouh Ahmed
- Numero di telefono: +201001066756
- Email: abulfotouhahmed@yahoo.com
Luoghi di studio
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Cairo, Egitto
- Reclutamento
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
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Contatto:
- Abul-fotouh Ahmed
- Numero di telefono: +201001066756
- Email: abulfotouhahmed@yahoo.com
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
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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.
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All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical response to tadalafil at 12 weeks
Lasso di tempo: 12 weeks
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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.
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12 weeks
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in the International Index of Erectile Function erectile function score.
Lasso di tempo: Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Change in Erection Hardness Score
Lasso di tempo: Baseline and12 weeks.
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Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection.
Higher scores indicate firmer erections.
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Baseline and12 weeks.
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Brachial artery flow-mediated dilatation
Lasso di tempo: Baseline
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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.
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Baseline
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Carotid intima-media thickness
Lasso di tempo: Baseline
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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.
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Baseline
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Serum endothelin-1 level
Lasso di tempo: Baseline
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Baseline biomarker levels will be evaluated as independent predictors of treatment response.
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Baseline
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Serum nitrite/nitrate level
Lasso di tempo: Baseline
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Baseline biomarker levels will be evaluated as independent predictors of treatment response.
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Baseline
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Serum high-sensitivity C-reactive protein
Lasso di tempo: Baseline
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Baseline biomarker levels will be evaluated as independent predictors of treatment response.
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Baseline
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Adverse events during tadalafil treatment
Lasso di tempo: Throughout the 12-week treatment period.
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Number and type of treatment-emergent adverse events occurring during 12 weeks of tadalafil 5 mg once-daily therapy.
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Throughout the 12-week treatment period.
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Inibitori della fosfodiesterasi
- Piridine
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Azioni farmacologiche
- Azioni e usi chimici
- Indoli
- Alcaloidi indolo
- Composti eterociclici, 3 anelli
- Carboline
- Tadalafil
- Inibitori della fosfodiesterasi 5
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- UroAzhar_18_026
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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