L-Arginine and Tadalafil for Erectile Dysfunction
L-Arginine
+ Tadalafil 5 mg
Urogenital Diseases+5
+ Genital Diseases
+ Mental Disorders
Treatment Study
Summary
Study start date: January 14, 2024
Actual date on which the first participant was enrolled.This study is investigating the effectiveness and safety of different treatments for men experiencing erectile dysfunction (ED). ED is a condition where a man has trouble getting or keeping an erection suitable for sexual intercourse. The study focuses on men who have not been previously treated for mild to moderate ED. Participants are divided into three groups to compare how well L-arginine alone, Tadalafil alone, or a combination of both can help improve their condition. L-arginine is a natural substance that helps produce nitric oxide, which is important for erections, while Tadalafil is a widely used medication for ED. Understanding which treatment works best could improve treatment options for men with ED. Participants in the study will take their assigned treatment daily for eight weeks. Group 1 will take L-arginine, Group 2 will take Tadalafil, and Group 3 will take both L-arginine and Tadalafil. Before starting the treatment and after eight weeks, participants will have a series of assessments including medical history, physical exams, and laboratory tests like testosterone levels. They will also undergo a penile ultrasound to check tissue stiffness. Throughout the study, participants will be monitored for any side effects and changes in their ED condition using a questionnaire. The goal is to determine which treatment offers the best improvement in symptoms with the least side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 45 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * • Naive ( not previously treated) male patient with mild to moderate ED according to SHIM Questionnaire. Exclusion Criteria: * ● Kidney disease or liver failure * Coronary heart disease * Peyronie's disease * Neurological disease that may related to ED
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location