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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction and Neutrophil Lymphocyte Ratio
• Intervention / Treatment: Drug: Tadalafil 5mg/sildenafil 25 mg

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 Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed Diab Mohamed; Phone Number: 01501501772; Email: md01147169166@gmail.com
• Study Contact Backup: Name: Hisham diab gaber; Phone Number: 01009535577; Email: hishamdiabg@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University
    • Contact: AssiutU; Phone Number: +208822080150; Email: vpgrad@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tadalfil group; Patients will use daily tadalafil 5 mg for 2 months	Drug: Tadalafil 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; Other Names: blood sample before and after 2 months of medical tratment
EXPERIMENTAL: sildenafil group; Patients will use daily sildenafil 25 mg for 2 months	Drug: Tadalafil 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; Other Names: blood sample before and after 2 months of medical tratment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 .	2 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Link for article

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 16, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 16, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil
• Other Study ID Numbers: oral PDI5 and Blood components

Drug and device information, study documents

• 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