Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604903325533 Date of Registration: 23/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study of the association between erectile dysfunction and diastolic dysfunction, and the effect of different treatments in men with metabolic syndrome
Official scientific 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.
Brief summary describing the background and objectives of the trial Metabolic syndrome is associated with an increased risk of cardiovascular disease and is commonly accompanied by both erectile dysfunction (ED) and subclinical cardiac dysfunction. Erectile dysfunction shares multiple risk factors and pathophysiological mechanisms with cardiovascular disease, particularly endothelial dysfunction and microvascular impairment. Left ventricular diastolic dysfunction (LVDD) represents an early marker of cardiac involvement and may coexist with ED in patients with metabolic syndrome. This study aims to investigate the association between erectile dysfunction and left ventricular diastolic dysfunction in patients diagnosed with metabolic syndrome. Additionally, it evaluates the effect of different therapeutic strategies, including tadalafil and sodium-glucose cotransporter-2 inhibitors (SGLT2i), either alone or in combination, on both erectile function and diastolic function. In this randomized controlled trial, 60 male patients with metabolic syndrome and erectile dysfunction will be recruited and divided into three groups receiving tadalafil, SGLT2 inhibitors, or a combination of both for 3 months. Erectile function will be assessed using the International Index of Erectile Function (IIEF), while diastolic function will be evaluated using transthoracic echocardiography according to established guidelines. The study aims to clarify the relationship between ED and LVDD and to determine whether combined therapy provides additional benefits on both erectile and cardiac function in this patient population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) METDDED
Disease(s) or condition(s) being studied Cardiology,Nutritional, Metabolic, Endocrine,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2025
Actual trial start date 05/05/2025
Anticipated date of last follow up 15/03/2026
Actual Last follow-up date 17/03/2026
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
KFSIRB200 582 Scientific Research Ethics Committee, Kafrelsheikh University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Tadalafil Tadalafil 5 mg orally once daily 3 months Participants received tadalafil 5 mg once daily for 3 months. Erectile function, left ventricular diastolic function, and metabolic parameters were assessed at baseline and after completion of treatment. 20 Active-Treatment of Control Group
Experimental Group Dapagliflozin or empagliflozin SGLT-2 inhibitors 10 mg orally once daily 3 months Participants received SGLT-2 inhibitors 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. 20
Experimental Group Dapagliflozin or empagliflozin plus tadalafil Tadalafil 5 mg once daily plus SGLT2 inhibitors 10 mg once daily 3 months Participants received combination therapy with tadalafil 5 mg and SGLT2 inhibitor 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. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male patient aged 18 years or older Sexual relationship within the past 6 months and complaining of ED for at least 3 months (Erectile dysfunction defined as IIEF-6 score ≤ 25) Patients diagnosed with metabolic syndrome LV systolic dysfunction (EF less than 50%) Recent myocardial infarction (Within 1 month). Moderate to severe valvular lesion (stenosis or regurge). Renal Failure (eGFR less than 20 ml/min) Major pelvic surgery Significant CNS injury Spinal cord injuries Patients with hypothyroidism, hypogonadism, premature ejaculation. Current balanitis and urogenital infections History of orthostatic hypotension and other contraindications reported in the tadalafil and SGLT2i technical data sheets. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 41 Year(s) 73 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2025 Scientific Research Ethics Committee Kafrelsheikh University
Ethics Committee Address
Street address City Postal code Country
Kafrelsheikh University, El-Geish Street, Kafrelsheikh city, Kafrelsheikh governorate, Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in erectile function as assessed by the International Index of Erectile Function Baseline and after three months of treatment
Secondary Outcome Change in left ventricular diastolic function assessed by echocardiographic parameters Baseline and after three months of treatment
Secondary Outcome Correlation between changes in IIEF score and Echocardiographic parameters Baseline and after three months of treatment
Secondary Outcome Predictors of delta change in IIEF score Baseline and after three months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafr Elshiekh Univeristy Kafrelsheikh University, El-Geish Street, Kafrelsheikh, Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed brahim Shoghy .. self funded by the principal investigator Kafr ElSheikh University, El-Geish street Kafr ElSheikh 33516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine at Kafrelsheikh University Kafrelsheikh University, El-Geish street Kafr ElSheikh 33516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Shoghy Ahmed.med_0601@med.kfs.edu.eg 201062848476 Faculty of medicine, Kafrelshiekh University
City Postal code Country Position/Affiliation
Kafrelshiekh 33516 Egypt Cardiology Resident at Kafrelsheikh University Hospital Kafrelsheikh University
Role Name Email Phone Street address
Public Enquiries Ahmed Shoghy Ahmed.med_0601@med.kfs.edu.eg 201062848476 Kafrelsheikh University, El-Geish Road
City Postal code Country Position/Affiliation
Kafrelsheikh 33516 Egypt Cardiology Resident at Kafrelsheikh University Hospital at Kafrelsheikh University
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbdelRaouf Mohamed.gamil@med.kfs.edu.eg 201008588843 Kafr El-Sheikh University, El-Geish Road
City Postal code Country Position/Affiliation
Kafrelsheikh 33516 Egypt Lecturer of cardiology at Kafrelshiekh university faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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. Statistical Analysis Plan,Study Protocol Data will be available starting 6 months after publication and will remain available for up to 2 years. Access will be granted to qualified researchers upon reasonable request, subject to approval by the principal investigator and institutional ethics committee, and after signing a data sharing agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 23/04/2026 Corrected exclusion criteria (EF <50%) to align with the study protocol; this update was communicated via email, too. LV systolic dysfunction (EF > 50%) Recent myocardial infarction (Within 1 month). Moderate to severe valvular lesion (stenosis or regurge). Renal Failure (eGFR less than 20 ml/min) Major pelvic surgery Significant CNS injury Spinal cord injuries Patients with hypothyroidism, hypogonadism, premature ejaculation. Current balanitis and urogenital infections History of orthostatic hypotension and other contraindications reported in the tadalafil and SGLT2i technical data sheets. LV systolic dysfunction (EF less than 50%) Recent myocardial infarction (Within 1 month). Moderate to severe valvular lesion (stenosis or regurge). Renal Failure (eGFR less than 20 ml/min) Major pelvic surgery Significant CNS injury Spinal cord injuries Patients with hypothyroidism, hypogonadism, premature ejaculation. Current balanitis and urogenital infections History of orthostatic hypotension and other contraindications reported in the tadalafil and SGLT2i technical data sheets.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 23/04/2026 Revised funding source based on reviewer feedback No external funding, Kafr ElSheikh University, El-Geish street, Kafr ElSheikh, 33516, Egypt, Self Funded, Ahmed brahim Shoghy .. self funded by the principal investigator , Kafr ElSheikh University, El-Geish street, Kafr ElSheikh, 33516, Egypt, Self Funded,