Erectile Dysfunction Associated With Type 2 Diabetes MellitusNCT06962462
Daily Tadalafil in Diabetic ED Patients
A study of Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by South Valley University.
Trial summary
This study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction. Outcomes will be compared pre- and post-treatment versus healthy controls. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 30 Aug 2025
- Phase
- Interventional
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients aged between 30 and 60 yearsز Diagnosed with diabetes mellitus Suffering from erectile dysfunction No history of hypertension or other systemic diseases
Who cannot join
- History of pelvic trauma or major pelvic surgery Pacientes con hipogonadismo o hiperprolactinemia Chronic liver disease or cardiovascular disorders Chronic use of central nervous system drugs, anti-androgenic drugs, or Tramadol Smokers Non-vasculogenic erectile dysfunction Known allergy to tadalafil
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Daily Tadalafil Therapy on Endothelin-1 and E-Selectin in Diabetic Patients With Erectile Dysfunction
This study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction. Outcomes will be compared pre- and post-treatment versus healthy controls.
- Being tested
- Methyl Cellulose Placebo
- Keywords
- Tadalafil, Endothelin-1, E-selectin, Diabetic complications, Sexual dysfunction, ELISA
- Medical subject headings
- Diabetes Complications, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Cellulose PlaceboDrug
Oral administration of inert methyl cellulose placebo tablets once daily for 3 months. Used as a comparator in healthy control participants to evaluate changes in Endothelin-1 and E-selectin serum levels.
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil Group | Experimental | Diabetic male patients with erectile dysfunction will receive oral tadalafil 5 mg once daily for 3 months to assess changes in serum Endothelin-1 and E-selectin levels. Receives: Drug: Methyl Cellulose Placebo |
| Placebo Group | Placebo comparator | Healthy male participants matched by age will receive oral placebo tablets (methyl cellulose) once daily for 3 months. Blood samples will be collected pre- and post-intervention for biomarker assessment. Receives: Drug: Methyl Cellulose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin
Measurement of serum Endothelin-1 and E-selectin concentrations in diabetic patients with erectile dysfunction, before and after daily tadalafil 5 mg for 3 months, using ELISA technique.
Measured: 3 months after intervention
Secondary outcomes (1)
Biochemical assessment of serum Endothelin-1 and E-selectin levels
Measurement of serum levels of Endothelin-1 and E-selectin in diabetic patients with erectile dysfunction using ELISA technique before and after tadalafil 5 mg daily treatment.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 May 2025 (estimated)
- Primary completion5 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Associated With Type 2 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khalid Abdelmawgoud, South Valley University
- Investigators
- Abdelmawgoud, M.Sc, Principal investigator, Faculty of Medicine, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962462
- Sponsor's protocol ID
- DR-AKA-001
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Tadalafil Therapy on Endothelin-1 and E-Selectin in Diabetic Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06962462
- Acronym / sponsor ID
- DR-AKA-001
- Keywords
- Tadalafil, Endothelin-1, E-selectin, Diabetic complications, Sexual dysfunction, ELISA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 8 May 2025 (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 study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction. Outcomes will be compared pre- and post-treatment versus healthy controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil Group | Experimental | Drug: Methyl Cellulose PlaceboDiabetic male patients with erectile dysfunction will receive oral tadalafil 5 mg once daily for 3 months to assess changes in serum Endothelin-1 and E-selectin levels. |
| Placebo Group | Placebo comparator | Drug: Methyl Cellulose PlaceboHealthy male participants matched by age will receive oral placebo tablets (methyl cellulose) once daily for 3 months. Blood samples will be collected pre- and post-intervention for biomarker assessment. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male patients aged between 30 and 60 yearsز Diagnosed with diabetes mellitus Suffering from erectile dysfunction No history of hypertension or other systemic diseases
Key exclusion criteria (1 listed)
- History of pelvic trauma or major pelvic surgery Pacientes con hipogonadismo o hiperprolactinemia Chronic liver disease or cardiovascular disorders Chronic use of central nervous system drugs, anti-androgenic drugs, or Tramadol Smokers Non-vasculogenic erectile dysfunction Known allergy to tadalafil
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 |
|---|---|---|
| Methyl Cellulose PlaceboOral administration of inert methyl cellulose placebo tablets once daily for 3 months. Used as a comparator in healthy control participants to evaluate changes in Endothelin-1 and E-selectin serum levels. | Drug | Placebo Group, Tadalafil Group |
Primary outcome
Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin
Time frame: 3 months after intervention
Measurement of serum Endothelin-1 and E-selectin concentrations in diabetic patients with erectile dysfunction, before and after daily tadalafil 5 mg for 3 months, using ELISA technique.
1 secondary outcome
Biochemical assessment of serum Endothelin-1 and E-selectin levels
Time frame: 3 months after intervention
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 8 May 2025.
- Individual participant dataSharing planned: No
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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.
Abdelmawgoud, M.Sc principal investigator
Faculty of Medicine, South Valley University
Questions about this trial
What is this clinical trial studying?
A study of Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by South Valley University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Ahmed K Abdelmawgoud, M.Sc (01066152814 ext. +20, amed66177@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin (time frame: 3 months after intervention). 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 8 May 2025.