Vasculogenic Erectile DysfunctionNCT07773103
Endothelial Markers and Tadalafil Response
An observational study of Vasculogenic Erectile Dysfunction, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic. Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Vasculogenic Erectile Dysfunction
- What is being tested?
- Tadalafil 5mg
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.
Who may be able to join
- Participants must fulfill all of the following:
- Men aged 30 to 70 years.
- ED lasting at least 3 months.
- IIEF-5/SHIM score of 21 or less or clinically documented ED.
- Clinical features suggesting predominantly vasculogenic ED.
- Sexually active or willing to attempt sexual intercourse during the study.
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- Able to complete the study questionnaires.
- Willing to take tadalafil 5 mg once daily for 12 weeks.
- Able to provide written informed consent.
- Willing to avoid other ED treatments during the study unless medically necessary.
Who cannot join
- Patients will be excluded if they have:
- ED primarily attributed to psychogenic causes.
- Predominantly neurogenic ED.
- Severe untreated hypogonadism likely to be the primary cause of ED.
- Untreated hyperprolactinemia or another major endocrine disorder.
- Significant penile anatomical abnormality interfering with intercourse, including severe Peyronie's disease.
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- Previous radical pelvic surgery or pelvic radiotherapy.
- Active urinary or genital infection.
- Unstable angina or unstable cardiovascular disease.
- Recent myocardial infarction or stroke.
- Uncontrolled hypertension or clinically significant hypotension.
- Severe renal impairment requiring an alternative tadalafil regimen.
- Severe hepatic impairment.
- Active malignancy or expected survival of less than one year.
- Major psychiatric illness, cognitive impairment or inability to comply with follow-up.
- Current use of another PDE5 inhibitor or intracavernosal therapy that cannot be discontinued.
- Concomitant use of organic nitrates, nitric oxide donors or nicorandil.
- Known hypersensitivity to tadalafil.
- Participation in another study that may affect erectile function or vascular measurements.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo
Abul-fotouh Ahmed, +201001066756, abulfotouhahmed@yahoo.com
About this study
Official title: Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction
This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic. Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation, carotid intima-media thickness, and selected circulating endothelial biomarkers including endothelin-1, nitrite/nitrate, high-sensitivity C-reactive protein, soluble vascular cell adhesion molecule-1, and soluble intercellular adhesion molecule-1. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function, adherence, and adverse events will be assessed during follow-up. The primary outcome will be clinical response at 12 weeks, defined as an improvement of at least 4 points in the IIEF-EF domain together with a positive response to the Global Assessment Question.
Read the detailed description
Erectile dysfunction is a common male sexual disorder and is often associated with endothelial dysfunction, impaired nitric oxide bioavailability, inflammation, arterial stiffness, and subclinical atherosclerosis. Because penile arteries are relatively small, vasculogenic erectile dysfunction may appear before overt cardiovascular disease. Brachial artery flow-mediated dilatation reflects endothelial-dependent vasodilation, carotid intima-media thickness reflects structural vascular change, and circulating endothelial biomarkers may provide additional information about endothelial injury and inflammation.
This prospective observational cohort study will recruit men with predominantly vasculogenic erectile dysfunction attending the Urology/Andrology outpatient clinic. Baseline demographic, clinical, sexual, laboratory, vascular, and biomarker data will be collected before treatment. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function will be measured again at follow-up using the IIEF-EF domain, IIEF-5/SHIM, and the Global Assessment Question. The primary outcome is clinical response at 12 weeks, defined as an improvement of at least 4 points in IIEF-EF together with a positive Global Assessment Question response. The study will also evaluate whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.
- Conditions
- Vasculogenic Erectile Dysfunction
- Being tested
- Tadalafil 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called PDE5 inhibitor
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil 5 mg once daily | Adult men with predominantly vasculogenic erectile dysfunction who are eligible for tadalafil 5 mg once daily and enrolled in this prospective cohort study. Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to tadalafil at 12 weeks
Proportion of participants achieving clinical response, defined as an increase of at least 4 points in the IIEF-EF domain score from baseline together with a positive response to the Global Assessment Question. The IIEF-EF domain scores erectile function on a higher-is-better scale; higher scores indicate better erectile function.
Measured: 12 weeks
Secondary outcomes (8)
Change in the International Index of Erectile Function erectile function score.
Change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF). The IIEF-EF domain is a validated erectile function score, with higher values indicating better erectile function.
Measured: Baseline to 12 weeks
Change in Erection Hardness Score
Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection. Higher scores indicate firmer erections.
Measured: Baseline and12 weeks.
Brachial artery flow-mediated dilatation
Association between baseline brachial artery flow-mediated dilatation percentage and clinical response to tadalafil. Flow-mediated dilatation is a functional ultrasound-based measure of endothelial-dependent vasodilation; lower values indicate worse endothelial function. Baseline FMD will be evaluated as an independent predictor of treatment response.
Measured: Baseline
Carotid intima-media thickness
Association between baseline mean carotid intima-media thickness and clinical response to tadalafil. Carotid intima-media thickness is a structural ultrasound marker of subclinical atherosclerosis; higher values indicate more advanced vascular wall thickening. Baseline CIMT will be evaluated as an independent predictor of treatment response.
Measured: Baseline
Serum endothelin-1 level
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Measured: Baseline
Serum nitrite/nitrate level
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Measured: Baseline
Serum high-sensitivity C-reactive protein
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Measured: Baseline
Adverse events during tadalafil treatment
Number and type of treatment-emergent adverse events occurring during 12 weeks of tadalafil 5 mg once-daily therapy.
Measured: Throughout the 12-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start19 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasculogenic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, Principal investigator, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773103
- Sponsor's protocol ID
- UroAzhar_18_026
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07773103
- Acronym / sponsor ID
- UroAzhar_18_026
- Conditions
- Vasculogenic Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 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.
This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic. Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation, carotid intima-media thickness, and selected circulating endothelial biomarkers including endothelin-1, nitrite/nitrate, high-sensitivity C-reactive protein, soluble vascular cell adhesion molecule-1, and soluble intercellular adhesion molecule-1. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function, adherence, and adverse events will be assessed during follow-up. The primary outcome will be clinical response at 12 weeks, defined as an improvement of at least 4 points in the IIEF-EF domain together with a positive response to the Global Assessment Question.
Detailed description
Erectile dysfunction is a common male sexual disorder and is often associated with endothelial dysfunction, impaired nitric oxide bioavailability, inflammation, arterial stiffness, and subclinical atherosclerosis. Because penile arteries are relatively small, vasculogenic erectile dysfunction may appear before overt cardiovascular disease. Brachial artery flow-mediated dilatation reflects endothelial-dependent vasodilation, carotid intima-media thickness reflects structural vascular change, and circulating endothelial biomarkers may provide additional information about endothelial injury and inflammation.
This prospective observational cohort study will recruit men with predominantly vasculogenic erectile dysfunction attending the Urology/Andrology outpatient clinic. Baseline demographic, clinical, sexual, laboratory, vascular, and biomarker data will be collected before treatment. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function will be measured again at follow-up using the IIEF-EF domain, IIEF-5/SHIM, and the Global Assessment Question. The primary outcome is clinical response at 12 weeks, defined as an improvement of at least 4 points in IIEF-EF together with a positive Global Assessment Question response. The study will also evaluate whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tadalafil 5 mg once daily | – | Drug: Tadalafil 5mgAdult men with predominantly vasculogenic erectile dysfunction who are eligible for tadalafil 5 mg once daily and enrolled in this prospective cohort study. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.
Key inclusion criteria (10 listed)
- Participants must fulfill all of the following:
Key exclusion criteria (20 listed)
- Patients will be excluded if they have:
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 5mgAlso: PDE5 inhibitorAll enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management. | Drug | Tadalafil 5 mg once daily |
Primary outcome
Clinical response to tadalafil at 12 weeks
Time frame: 12 weeks
Proportion of participants achieving clinical response, defined as an increase of at least 4 points in the IIEF-EF domain score from baseline together with a positive response to the Global Assessment Question. The IIEF-EF domain scores erectile function on a higher-is-better scale; higher scores indicate better erectile function.
8 secondary outcomes
Change in the International Index of Erectile Function erectile function score.
Time frame: Baseline to 12 weeks
Change in Erection Hardness Score
Time frame: Baseline and12 weeks.
Brachial artery flow-mediated dilatation
Time frame: Baseline
Carotid intima-media thickness
Time frame: Baseline
Serum endothelin-1 level
Time frame: Baseline
Serum nitrite/nitrate level
Time frame: Baseline
Serum high-sensitivity C-reactive protein
Time frame: Baseline
Adverse events during tadalafil treatment
Time frame: Throughout the 12-week treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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The Feasibility of Using Dornier Machine in Patients With Erectile Dysfunction, a Pilot Study.
Erectile Dysfunction (ED)
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.
Abul-fotouh Ahmed principal investigator
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculogenic Erectile Dysfunction, run by Al-Azhar 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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 20 Aug 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abul-fotouh Ahmed (+201001066756, abulfotouhahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to tadalafil at 12 weeks (time frame: 12 weeks). 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 20 Aug 2026.