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

NCT ID: NCT05466695

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-01

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

Conditions

Erectile Dysfunction and Neutrophil Lymphocyte Ratio

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tadalfil group

Patients will use daily tadalafil 5 mg for 2 months

Group Type: EXPERIMENTAL

Tadalafil 5mg/sildenafil 25 mg

Intervention Type: DRUG

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

sildenafil group

Patients will use daily sildenafil 25 mg for 2 months

Group Type: EXPERIMENTAL

Tadalafil 5mg/sildenafil 25 mg

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

blood sample before and after 2 months of medical tratment

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mohamed diab mohamed ramadan

Resident physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Mohamed Diab Mohamed

Role: CONTACT

md01147169166@gmail.com

01501501772

Hisham diab gaber

Role: CONTACT

hishamdiabg@yahoo.com

01009535577

Facility Contacts

AssiutU

Role: primary

vpgrad@aun.edu.eg

+208822080150

Other Identifiers

oral PDI5 and Blood components

Identifier Type: -

Identifier Source: org_study_id