Daily Tadalafil in Diabetic ED Patients

Not Applicable

Not yet recruiting

• Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
• Interventions: Drug: Methyl Cellulose Placebo

• Registration Number: NCT06962462
• Lead Sponsor: South Valley University

Brief Summary

This study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction. Outcomes will be compared pre- and post-treatment versus healthy controls.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study Start: 2025-05-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-08-05
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Male patients aged between 30 and 60 yearsز Diagnosed with diabetes mellitus Suffering from erectile dysfunction No history of hypertension or other systemic diseases

Exclusion Criteria

History of pelvic trauma or major pelvic surgery Pacientes con hipogonadismo o hiperprolactinemia Chronic liver disease or cardiovascular disorders Chronic use of central nervous system drugs, anti-androgenic drugs, or Tramadol Smokers Non-vasculogenic erectile dysfunction Known allergy to tadalafil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tadalafil Group	Methyl Cellulose Placebo	Diabetic male patients with erectile dysfunction will receive oral tadalafil 5 mg once daily for 3 months to assess changes in serum Endothelin-1 and E-selectin levels.
Placebo Group	Methyl Cellulose Placebo	Healthy male participants matched by age will receive oral placebo tablets (methyl cellulose) once daily for 3 months. Blood samples will be collected pre- and post-intervention for biomarker assessment.

Primary Outcome Measures

Name	Time	Method
Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin	3 months after intervention	Measurement of serum Endothelin-1 and E-selectin concentrations in diabetic patients with erectile dysfunction, before and after daily tadalafil 5 mg for 3 months, using ELISA technique.

Secondary Outcome Measures

Name	Time	Method
Biochemical assessment of serum Endothelin-1 and E-selectin levels	3 months after intervention	Measurement of serum levels of Endothelin-1 and E-selectin in diabetic patients with erectile dysfunction using ELISA technique before and after tadalafil 5 mg daily treatment.