Erectile Dysfunction and Neutrophil Lymphocyte RatioEarly Phase 1NCT05466695
Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response
A Early Phase 1 study testing Tadalafil 5mg/sildenafil 25 mg in people with Erectile Dysfunction and Neutrophil Lymphocyte Ratio, run by Assiut University at 1 site in Egypt.
Trial summary
1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction and Neutrophil Lymphocyte Ratio
- What is being tested?
- Tadalafil 5mg/sildenafil 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Early Phase 1
- 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 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients with mild,moderate and severe erectile dysfunction.
- Age from 25 to 60 years.
Who cannot join
- · Severe uncontrolled medical condition(DM,HTN).
- Patients under treatment with sublingual nitrate .
- Patients with blood diseases that affect sexual function (Leukaemia).
- Patients using cytotoxic drugs or immunosuppressive drugs.
- Single patient.
Trial locations and contacts
1 site in 1 country.
About this study
1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients.
Read the detailed description
Erectile dysfunction (ED) is an inability to provide adequate erection to initiate or maintain any sexual activity. The ED prevalence in adult males is approximately 20%. Cardiovascular diseases, diabetes mellitus(DM), chronic systemic diseases, smoking and obesity are among the aetiology of ED .In recent years, publications indicating that active inflammatory processes cause ED are increasing. In these studies where neutrophil- lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) were used as signs of inflammation, a significant relationship was found between diseases with these proportions .Neutrophil-to-lymphocyte ratio (NLR) is a simple parameter to assess easily the inflammatory status of a subject. It has proven its usefulness in the stratification of mortality in major cardiac events , as a strong prognostic factor in several types of cancers , or as a predictor and a marker of inflammatory or infectious pathologies (such is pediatric appendicitis) and postoperative complications. Through enhanced production of cytokines and expression of cellular adhesion molecules, the dysfunctional endothelium promotes inflammation within the vascular wall and sets the stage for initiation and progression of atherosclerotic lesions in both penile vasculature and in peripheral and coronary blood vessels. It has been shown that patients with vasculogenic ED have increased inflammatory activation compared to subjects without ED.There are numerous studies suggesting that phosphodiesterase-5(PDE-5) inhibitors, which are the first-line therapy of ED, might be effective in reversing generalized endothelial dysfunction. Chronic treatment restores endothelium-dependent relaxations at various sites of the vascular tree, even up to one week after cessation of the treatment . Previous studies reported a chronic effect of sildenafil and tadalafil on endothelial function and pro-inflammatory markers/mediators including intercellular and vascular cell adhesion molecules-1 (ICAM-1 and VCAM-1, respectively), high sensitivity C-reactive protein (hsCRP), and interleukin-6
- Being tested
- Tadalafil 5mg/sildenafil 25 mg
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mg/sildenafil 25 mgDrug
Also called blood sample before and after 2 months of medical tratment
patients will use daily tadalafil or daily sildenafil for 2 months blood sample will be obtained before and after 2 months and also IIEF-5 score for clinical response
| Study group | Role | What they receive |
|---|---|---|
| tadalfil group | Experimental | Patients will use daily tadalafil 5 mg for 2 months Receives: Drug: Tadalafil 5mg/sildenafil 25 mg |
| sildenafil group | Experimental | Patients will use daily sildenafil 25 mg for 2 months Receives: Drug: Tadalafil 5mg/sildenafil 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of tadalafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Effect of daily tadalfil 5 mg on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios
Measured: 2 months
Effect of sildenafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Effect of sildenafil 25 mg daily on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction and Neutrophil Lymphocyte RatioStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will use daily tadalafil 5 mg or daily sildenafil 25 mg 4. Assessment of the grade of erectile dysfunction using international index of erectile function-5.The patients whose international Index of Erectile Function-5 (IIEF-5) scores varied between 5-7 are considered to have severe and 8-16 are considered to have moderate and 17-21 are considered to have mild erectile dysfunction. 2\. Blood sample will be obtained before and after 2 months of medical treatment to measure neutrophil-lymphocyte and platelet-lymphocyte ratios.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed diab mohamed ramadan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466695
- Sponsor's protocol ID
- oral PDI5 and Blood components
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 20 Jul 2022
- 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 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response
- ClinicalTrials.gov ID
- NCT05466695
- Acronym / sponsor ID
- oral PDI5 and Blood components
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 20 Jul 2022 (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.
1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients.
Detailed description
Erectile dysfunction (ED) is an inability to provide adequate erection to initiate or maintain any sexual activity. The ED prevalence in adult males is approximately 20%. Cardiovascular diseases, diabetes mellitus(DM), chronic systemic diseases, smoking and obesity are among the aetiology of ED .In recent years, publications indicating that active inflammatory processes cause ED are increasing. In these studies where neutrophil- lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) were used as signs of inflammation, a significant relationship was found between diseases with these proportions .Neutrophil-to-lymphocyte ratio (NLR) is a simple parameter to assess easily the inflammatory status of a subject. It has proven its usefulness in the stratification of mortality in major cardiac events , as a strong prognostic factor in several types of cancers , or as a predictor and a marker of inflammatory or infectious pathologies (such is pediatric appendicitis) and postoperative complications. Through enhanced production of cytokines and expression of cellular adhesion molecules, the dysfunctional endothelium promotes inflammation within the vascular wall and sets the stage for initiation and progression of atherosclerotic lesions in both penile vasculature and in peripheral and coronary blood vessels. It has been shown that patients with vasculogenic ED have increased inflammatory activation compared to subjects without ED.There are numerous studies suggesting that phosphodiesterase-5(PDE-5) inhibitors, which are the first-line therapy of ED, might be effective in reversing generalized endothelial dysfunction. Chronic treatment restores endothelium-dependent relaxations at various sites of the vascular tree, even up to one week after cessation of the treatment . Previous studies reported a chronic effect of sildenafil and tadalafil on endothelial function and pro-inflammatory markers/mediators including intercellular and vascular cell adhesion molecules-1 (ICAM-1 and VCAM-1, respectively), high sensitivity C-reactive protein (hsCRP), and interleukin-6
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will use daily tadalafil 5 mg or daily sildenafil 25 mg 4. Assessment of the grade of erectile dysfunction using international index of erectile function-5.The patients whose international Index of Erectile Function-5 (IIEF-5) scores varied between 5-7 are considered to have severe and 8-16 are considered to have moderate and 17-21 are considered to have mild erectile dysfunction. 2. Blood sample will be obtained before and after 2 months of medical treatment to measure neutrophil-lymphocyte and platelet-lymphocyte ratios.
| Arm | Type | Receives |
|---|---|---|
| tadalfil group | Experimental | Drug: Tadalafil 5mg/sildenafil 25 mgPatients will use daily tadalafil 5 mg for 2 months |
| sildenafil group | Experimental | Drug: Tadalafil 5mg/sildenafil 25 mgPatients will use daily sildenafil 25 mg for 2 months |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male patients with mild,moderate and severe erectile dysfunction.
- Age from 25 to 60 years.
Key exclusion criteria (5 listed)
- · Severe uncontrolled medical condition(DM,HTN).
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 5mg/sildenafil 25 mgAlso: blood sample before and after 2 months of medical tratmentpatients will use daily tadalafil or daily sildenafil for 2 months blood sample will be obtained before and after 2 months and also IIEF-5 score for clinical response | Drug | sildenafil group, tadalfil group |
Primary outcome
Effect of tadalafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Time frame: 2 months
Effect of daily tadalfil 5 mg on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios
Effect of sildenafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Time frame: 2 months
Effect of sildenafil 25 mg daily on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tadalafil 5mg/sildenafil 25 mg in people with Erectile Dysfunction and Neutrophil Lymphocyte Ratio, run by Assiut 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Diab Mohamed (01501501772, md01147169166@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 on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios . (time frame: 2 months). The study lists 2 primary outcomes in all. 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 Jul 2022.