Daily Tadalafil in Diabetic ED Patients

NCT06962462 | Not Yet Recruiting DMC

• 1 other identifier: DR-AKA-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Keywords

Tadalafil, Endothelin-1, E-selectin, Diabetic complications, Sexual dysfunction, ELISA

Outcome Measures

Primary Outcomes (1)

• Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin

  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.

  3 months after intervention

Secondary Outcomes (1)

• Biochemical assessment of serum Endothelin-1 and E-selectin levels

  3 months after intervention

Study Arms (2)

Tadalafil Group

EXPERIMENTAL

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.

Drug: Methyl Cellulose Placebo

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Methyl Cellulose Placebo

Interventions

Methyl Cellulose Placebo DRUG

Oral administration of inert methyl cellulose placebo tablets once daily for 3 months. Used as a comparator in healthy control participants to evaluate changes in Endothelin-1 and E-selectin serum levels.

Placebo Group; Tadalafil Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

MeSH Terms

Conditions

Diabetes Complications; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Abdelmawgoud, M.Sc

  Faculty of Medicine, South Valley University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed K Abdelmawgoud, M.Sc

CONTACT

01066152814; amed66177@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 5, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share