Erectile DysfunctionPhase 4METDDEDNCT07563647
Association Between Diastolic Dysfunction and Erectile Dysfunction and the Effect of Tadalafil and SGLT2 Inhibitors on Them in Men With Metabolic Syndrome
A Phase 4 study testing Tadalafil 5 mg, SGLT-2 inhibitor and Tadalafil plus SGLT2 inhibitors in people with Erectile Dysfunction and Left Ventricular Diastolic Dysfunction, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Left Ventricular Diastolic Dysfunction, Metabolic Syndrome
- What is being tested?
- Tadalafil 5 mg, SGLT-2 inhibitor and Tadalafil plus SGLT2 inhibitors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2025to 17 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- * 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)
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- Endocrine disorders (hypothyroidism, hypogonadism)
- Premature ejaculation
- Current balanitis or urogenital infections
- History of orthostatic hypotension
- Any contraindications to tadalafil or SGLT2 inhibitors
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
Kafr ash Shaykh, Kafrelsheikh Governrate, 33511
About this study
Official title: A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.
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.
Read more
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.
Read the detailed description
This is a prospective, randomized, allocation-concealed, assessor-blinded, parallel-group clinical trial conducted at the Faculty of Medicine, Kafrelsheikh University. The study investigates the association between erectile dysfunction (ED) and left ventricular diastolic dysfunction (LVDD) in men with metabolic syndrome, and evaluates the effects of different treatment strategies on both conditions.
A total of 60 male patients aged 41 to 73 years diagnosed with metabolic syndrome and erectile dysfunction will be enrolled and randomly assigned into three parallel groups (1:1:1). The first group will receive tadalafil 5 mg once daily, the second group will receive an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg once daily), and the third group will receive a combination of both treatments. The duration of intervention is 3 months.
Randomization will be performed using permuted block randomization, with allocation concealment ensured by an independent sequence holder. Outcome assessors will be blinded to treatment allocation.
Baseline and follow-up assessments will include clinical evaluation, metabolic parameters, echocardiographic assessment of left ventricular diastolic function, and evaluation of erectile function using the International Index of Erectile Function (IIEF).
The primary outcome is the change in erectile function as assessed by IIEF score after 3 months of treatment. Secondary outcomes include changes in echocardiographic parameters of diastolic function, correlation between erectile function and diastolic dysfunction, and identification of predictors of improvement in erectile function.
The study aims to provide insight into the relationship between cardiovascular dysfunction and erectile dysfunction in patients with metabolic syndrome and to determine whether combined therapy offers additional benefits over monotherapy.
- Being tested
- Tadalafil 5 mg, SGLT-2 inhibitor, Tadalafil plus SGLT2 inhibitors
- Keywords
- Tadalafil, SGLT2 inhibitors, Diastolic function, Echocardiography, Endothelial dysfunction, Cardiovascular risk
- Medical subject headings
- Erectile Dysfunction, Ventricular Dysfunction, Left, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5 mgDrug
Tadalafil 5 mg once daily for three months
SGLT-2 inhibitorDrug
Also called Dapagliflozin, Empagliflozin
SGLT2 inhibitors 10 mg orally once daily for three months
Tadalafil plus SGLT2 inhibitorsDrug
Combination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil Group | Active comparator | Participants received tadalafil 5 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. Receives: Drug: Tadalafil 5 mg |
| SGLT2 inhibitors group | Experimental | Participants received SGLT2 inhibitors (dapagliflozin or empagliflozin) 10 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. Receives: Drug: SGLT-2 inhibitor |
| Combination therapy | Experimental | Participants received combination therapy with tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. Receives: Drug: Tadalafil plus SGLT2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Change in erectile function assessed by the International Index of Erectile Function (IIEF-6). The IIEF-6 is a validated questionnaire with scores ranging from 1 to 30, where higher scores indicate better erectile function. The outcome measure will be the change in IIEF-6 score from baseline to 3 months after treatment.
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in left ventricular diastolic function assessed by echocardiographic parameters
Left ventricular diastolic function will be assessed using specific echocardiographic parameters in accordance with ASE/EACVI guidelines, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg). Each parameter will be measured at baseline and at 3 months, and analyzed individually as components of overall diastolic function to evaluate changes over time.
Measured: Baseline and 3 months
Correlation between changes in IIEF score and echocardiographic parameters
Correlation between changes in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function) and changes in selected echocardiographic parameters of left ventricular diastolic function, including E/e' ratio, isovolumic relaxation time (IVRT, ms), deceleration time (DT, ms), and pulmonary artery systolic pressure (PASP, mmHg).
Measured: Baseline and 3 months
Predictors of change in IIEF score
Identification of independent predictors of change in erectile function assessed by the International Index of Erectile Function (IIEF-6) score (range: 1-30, higher scores indicate better erectile function). Predictors include selected clinical variables (age, years; smoking status, categorical), metabolic parameters (waist circumference, cm; systolic and diastolic blood pressure, mmHg; fasting blood glucose, mg/dL; HDL cholesterol, mg/dL; triglycerides, mg/dL), and specific echocardiographic parameters (E/e' ratio, unitless; isovolumic relaxation time [IVRT], ms; deceleration time [DT], ms; pulmonary artery systolic pressure [PASP], mmHg).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 May 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group interventional study in which eligible male patients with metabolic syndrome will be allocated into separate treatment arms. Each group will receive a specific intervention (e.g., tadalafil, SGLT2 inhibitors, or combination). Participants will remain in their assigned group throughout the study period without crossover. Outcomes, including erectile function and left ventricular diastolic function assessed by echocardiography, will be compared between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ahmed Ibrahim Shoghy, Kafrelsheikh University
- Investigators
- Reda B Bastawisy, MD (Professor), Study chair, Faculty of medicine, Kafrelshiekh universityWael A Haseeb, MD (Assistant professor), Study chair, Faculty of medicine, Kafrelshiekh universityMohamed G Abdelraouf, MD, Study chair, Faculty of medicine, Kafrelshiekh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563647
- Sponsor's protocol ID
- METDDED-01
- Other IDs
- PACTR202604903325533
- Acronym
- METDDED
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT07563647
- Acronym / sponsor ID
- METDDED / METDDED-01
- Keywords
- Tadalafil, SGLT2 inhibitors, Diastolic function, Echocardiography, Endothelial dysfunction, Cardiovascular risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, allocation-concealed, assessor-blinded, parallel-group clinical trial conducted at the Faculty of Medicine, Kafrelsheikh University. The study investigates the association between erectile dysfunction (ED) and left ventricular diastolic dysfunction (LVDD) in men with metabolic syndrome, and evaluates the effects of different treatment strategies on both conditions.
A total of 60 male patients aged 41 to 73 years diagnosed with metabolic syndrome and erectile dysfunction will be enrolled and randomly assigned into three parallel groups (1:1:1). The first group will receive tadalafil 5 mg once daily, the second group will receive an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg once daily), and the third group will receive a combination of both treatments. The duration of intervention is 3 months.
Randomization will be performed using permuted block randomization, with allocation concealment ensured by an independent sequence holder. Outcome assessors will be blinded to treatment allocation.
Baseline and follow-up assessments will include clinical evaluation, metabolic parameters, echocardiographic assessment of left ventricular diastolic function, and evaluation of erectile function using the International Index of Erectile Function (IIEF).
The primary outcome is the change in erectile function as assessed by IIEF score after 3 months of treatment. Secondary outcomes include changes in echocardiographic parameters of diastolic function, correlation between erectile function and diastolic dysfunction, and identification of predictors of improvement in erectile function.
The study aims to provide insight into the relationship between cardiovascular dysfunction and erectile dysfunction in patients with metabolic syndrome and to determine whether combined therapy offers additional benefits over monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, parallel-group interventional study in which eligible male patients with metabolic syndrome will be allocated into separate treatment arms. Each group will receive a specific intervention (e.g., tadalafil, SGLT2 inhibitors, or combination). Participants will remain in their assigned group throughout the study period without crossover. Outcomes, including erectile function and left ventricular diastolic function assessed by echocardiography, will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Tadalafil Group | Active comparator | Drug: Tadalafil 5 mgParticipants received tadalafil 5 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. |
| SGLT2 inhibitors group | Experimental | Drug: SGLT-2 inhibitorParticipants received SGLT2 inhibitors (dapagliflozin or empagliflozin) 10 mg orally once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. |
| Combination therapy | Experimental | Drug: Tadalafil plus SGLT2 inhibitorsParticipants received combination therapy with tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- * Left ventricular systolic dysfunction (EF less than 50%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 5 mgTadalafil 5 mg once daily for three months | Drug | Tadalafil Group |
| SGLT-2 inhibitorAlso: Dapagliflozin, EmpagliflozinSGLT2 inhibitors 10 mg orally once daily for three months | Drug | SGLT2 inhibitors group |
| Tadalafil plus SGLT2 inhibitorsCombination therapy with tadalafil 5 mg once daily and SGLT2 inhibitors 10 mg once daily for three months | Drug | Combination therapy |
Primary outcome
Change in erectile function assessed by the International Index of Erectile Function (IIEF)
Time frame: Baseline and 3 months
Change in erectile function assessed by the International Index of Erectile Function (IIEF-6). The IIEF-6 is a validated questionnaire with scores ranging from 1 to 30, where higher scores indicate better erectile function. The outcome measure will be the change in IIEF-6 score from baseline to 3 months after treatment.
3 secondary outcomes
Change in left ventricular diastolic function assessed by echocardiographic parameters
Time frame: Baseline and 3 months
Correlation between changes in IIEF score and echocardiographic parameters
Time frame: Baseline and 3 months
Predictors of change in IIEF score
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reda B Bastawisy, MD (Professor) study chair
Faculty of medicine, Kafrelshiekh university
Wael A Haseeb, MD (Assistant professor) study chair
Faculty of medicine, Kafrelshiekh university
Mohamed G Abdelraouf, MD study chair
Faculty of medicine, Kafrelshiekh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil 5 mg, SGLT-2 inhibitor and Tadalafil plus SGLT2 inhibitors in people with Erectile Dysfunction and Left Ventricular Diastolic Dysfunction, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erectile function assessed by the International Index of Erectile Function (IIEF) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.