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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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05466695
Enrollment
74
Registered
2022-07-20
Start date
2022-08-01
Completion date
2023-08-01
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction and Neutrophil Lymphocyte Ratio

Brief 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.

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

Interventions

DRUGTadalafil 5mg/sildenafil 25 mg

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Male patients with mild,moderate and severe erectile dysfunction. * Age from 25 to 60 years.

Exclusion criteria

* · 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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of tadalafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .2 monthsEffect 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 .2 monthsEffect of sildenafil 25 mg daily on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .

Countries

Egypt

Contacts

Primary ContactMohamed Diab Mohamed
md01147169166@gmail.com01501501772
Backup ContactHisham diab gaber
hishamdiabg@yahoo.com01009535577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026