Daily Tadalafil in Diabetic ED Patients

South Valley University

Status: Not yet enrolling

Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Treatments: Drug: Methyl Cellulose Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06962462

DR-AKA-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Tadalafil Group

Experimental group

Description:

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.

Treatment:

Drug: Methyl Cellulose Placebo

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Methyl Cellulose Placebo