Daily Tadalafil in Diabetic ED Patients

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.

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Key information

Conditions

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Diabetes Complications Diabetes Mellitus Endocrine System Diseases Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed K Abdelmawgoud, M.Sc

CONTACT

[email protected]

01066152814 ext. +20

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Effect of Daily Tadalafil Therapy on Endothelin-1 and E-Selectin in Diabetic Patients With Erectile Dysfunction

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 8, 2025
Registry last updated: May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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