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Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome

NCT07563647 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this study

Summary

Metabolic syndrome is associated with an increased risk of cardiovascular disease and is commonly accompanied by erectile dysfunction and subclinical cardiac dysfunction. Erectile dysfunction and left ventricular diastolic dysfunction may share common underlying mechanisms, including endothelial dysfunction and microvascular impairment.

This study aims to investigate the association between erectile dysfunction and left ventricular diastolic dysfunction in men with metabolic syndrome, and to evaluate the effects of different treatment strategies, including tadalafil and SGLT2 inhibitors, on both erectile function and cardiac diastolic function.

Participants will be randomly assigned to receive tadalafil, an SGLT2 inhibitor, or a combination of both for a duration of three months. Clinical, echocardiographic, and functional assessments will be performed at baseline and after treatment.

The results of this study may improve understanding of the link between cardiovascular and sexual dysfunction and help guide therapeutic approaches in this patient population.

Conditions

Interventions

DRUG

Tadalafil 5 mg

Tadalafil 5 mg once daily for three months

DRUG

SGLT-2 inhibitor

SGLT2 inhibitors 10 mg orally once daily for three months

DRUG

Tadalafil plus SGLT2 inhibitors

Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Reda B Bastawisy, MD (Professor) · Faculty of medicine, Kafrelshiekh university

  • Wael A Haseeb, MD (Assistant professor) · Faculty of medicine, Kafrelshiekh university

  • Mohamed G Abdelraouf, MD · Faculty of medicine, Kafrelshiekh university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2026-03-17
Completion
2026-03-17

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563647 on ClinicalTrials.gov