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Daily Tadalafil in Diabetic ED Patients

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06962462
Enrollment
60
Registered
2025-05-08
Start date
2025-05-05
Completion date
2025-08-30
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Keywords

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

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.

Interventions

DRUGMethyl Cellulose Placebo

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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin3 months after interventionMeasurement 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

MeasureTime frameDescription
Biochemical assessment of serum Endothelin-1 and E-selectin levels3 months after interventionMeasurement 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.

Contacts

Primary ContactAhmed K Abdelmawgoud, M.Sc
amed66177@gmail.com01066152814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026