- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07773103
Endothelial Markers and Tadalafil Response
Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Abul-fotouh Ahmed
- Número de teléfono: +201001066756
- Correo electrónico: abulfotouhahmed@yahoo.com
Ubicaciones de estudio
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Cairo, Egipto
- Reclutamiento
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
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Contacto:
- Abul-fotouh Ahmed
- Número de teléfono: +201001066756
- Correo electrónico: abulfotouhahmed@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical response to tadalafil at 12 weeks
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the International Index of Erectile Function erectile function score.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Mecanismos moleculares de acción farmacológica.
- Inhibidores de enzimas
- Inhibidores de la fosfodiesterasa
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Acciones farmacológicas
- Acciones y usos químicos
- Indoles
- Alcaloides de indol
- Compuestos heterocíclicos, 3 anillos
- Carbolines
- Tadalafilo
- Inhibidores de la fosfodiesterasa 5
Otros números de identificación del estudio
- UroAzhar_18_026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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