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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

Primary Purpose

Erectile Dysfunction and Neutrophil Lymphocyte Ratio

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Tadalafil 5mg/sildenafil 25 mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction and Neutrophil Lymphocyte Ratio

Eligibility Criteria

25 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tadalfil group

sildenafil group

Arm Description

Patients will use daily tadalafil 5 mg for 2 months

Patients will use daily sildenafil 25 mg for 2 months

Outcomes

Primary Outcome Measures

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
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 .

Secondary Outcome Measures

Full Information

First Posted
July 11, 2022
Last Updated
July 16, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05466695
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction and Neutrophil Lymphocyte Ratio

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tadalfil group
Arm Type
Experimental
Arm Description
Patients will use daily tadalafil 5 mg for 2 months
Arm Title
sildenafil group
Arm Type
Experimental
Arm Description
Patients will use daily sildenafil 25 mg for 2 months
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg/sildenafil 25 mg
Other Intervention Name(s)
blood sample before and after 2 months of medical tratment
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect of tadalafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Description
Effect of daily tadalfil 5 mg on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios
Time Frame
2 months
Title
Effect of sildenafil on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Description
Effect of sildenafil 25 mg daily on erectile dysfunction and neutrophil-lymphocyte and platelet-lymphocyte ratios .
Time Frame
2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Diab Mohamed
Phone
01501501772
Email
md01147169166@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hisham diab gaber
Phone
01009535577
Email
hishamdiabg@yahoo.com
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AssiutU
Phone
+208822080150
Email
vpgrad@aun.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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