Daily Tadalafil in Diabetic ED Patients

NCT ID: NCT06962462

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-08-30

Brief Summary

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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

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Conditions

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Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tadalafil Group

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.

Group Type EXPERIMENTAL

Methyl Cellulose Placebo

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Methyl Cellulose Placebo

Intervention Type 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.

Interventions

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Methyl 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Khalid Abdelmawgoud

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelmawgoud, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, South Valley University

Central Contacts

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Ahmed K Abdelmawgoud, M.Sc

Role: CONTACT

01066152814 ext. +20

Other Identifiers

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DR-AKA-001

Identifier Type: -

Identifier Source: org_study_id

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