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Can a pill fix both ED and heart trouble? new combo shows promise

NCT ID NCT07563647

Disease control Sponsor: Kafrelsheikh University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 60 men with metabolic syndrome who also had erectile dysfunction and early signs of heart stiffness. Researchers compared three treatments: tadalafil (a common ED drug), an SGLT2 inhibitor (a diabetes drug), and a combination of both, given for three months. The goal was to see if these drugs could improve both sexual function and heart relaxation, and to understand how these conditions are linked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

60 people

The number who actually took part.

Started

May 2025

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male patients aged ≥18 years * History of sexual activity within the past 6 months * Erectile dysfunction for at least 3 months (defined as IIEF-6 score ≤25) * Diagnosed with metabolic syndrome Exclusion Criteria: * \* Left ventricular systolic dysfunction (EF less than 50%) * Recent myocardial infarction (within 1 month) * Moderate to severe valvular heart disease (stenosis or regurgitation) * Renal failure (eGFR \<20 ml/min) * Major pelvic surgery * Significant central nervous system injury (e.g., spinal cord injury) * Endocrine disorders (hypothyroidism, hypogonadism) * Premature ejaculation * Current balanitis or urogenital infections * History of orthostatic hypotension * Any contraindications to tadalafil or SGLT2 inhibitors

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome erectile dysfunction metabolic syndrome X Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction Left ventricular diastolic dysfunction Metabolic syndrome

Contacts and locations

Locations

  • Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

    Kafr ash Shaykh, Kafrelsheikh Governrate, 33511, Egypt

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