Completed

L-Arginine and Tadalafil for Erectile Dysfunction

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What is being tested

L-Arginine

+ Tadalafil 5 mg

Drug
Who is being recruted

Urogenital Diseases+5

+ Genital Diseases

+ Mental Disorders

From 45 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorFayoum University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleSafety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study
Principal SponsorFayoum University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleErectile DysfunctionSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMale Urogenital Diseases

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.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
was given daily 3 g(three divided doses) oral tablets of L-arginine for eight weeks

Group II

Experimental
was given daily 3 g oral tablets of L-arginine and 5 mg oral tablets of Tadalafil for eight weeks.

Group III

Experimental
was given daily 5 mg oral tablets of Tadalafil for eight weeks.

Study 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

Suspended

Mohamed Mahmoud Dogha

Al Fayyum, EgyptOpen Mohamed Mahmoud Dogha in Google Maps
CompletedOne Study Center