Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study

NCT06947265 | Completed Phase 4 DMC

• 1 other identifier: D 355
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Sexual dysfunctions are annoying health problems with the erectile problems forming the main part of them. Erectile dysfunction (ED) is defined as the persistent inability to obtain or maintain an erection that is sufficient to allow satisfactory sexual intercourse.\[1\] Aim of Work To evaluate the role of L-arginine monotherapy versus Tadalafil monotherapy versus their combination for the treatment of erectile dysfunction . Patients and methods: 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

Conditions

Erectile Dysfunctions

Keywords

erectile dysfunction , L-arginine , elastography

Outcome Measures

Primary Outcomes (1)

• SHIM questionnaire

  The SHIM (Sexual Health Inventory for Men) questionnaire is a commonly used tool for assessing erectile dysfunction (ED) in men. It is a brief, self-administered questionnaire that typically consists of five questions, with answers scored on a scale to help determine the severity of erectile dysfunction. The SHIM is widely used in both clinical practice and research to assess sexual health and function. Here are the key elements of the SHIM: Frequency of sexual activity (often using a scale from "almost never or never" to "almost always or always"). Confidence in maintaining an erection (again, on a similar scale). Ability to achieve an erection. Erection firmness (whether the erection is hard enough for penetration). Satisfaction with the firmness of the erection. The scores are typically aggregated into one overall score, and depending on the score, it classifies the degree of erectile dysfunction: 25-22: No erectile dysfunction 21-17: Mild erectile dysfunction 16-12: Mild to mod

  8 weeks of treatment

Secondary Outcomes (2)

• testosterone level

  8 weeks of treatment

• Shear Wave Elastography

  8 weeks of treatment

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: L-Arginine

Group B

EXPERIMENTAL

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

Drug: Tadalafil 5 mg

Group C

EXPERIMENTAL

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

Drug: L-Arginine; Drug: Tadalafil 5 mg

Interventions

L-Arginine DRUG

get 3 gm oral tablets of L-arginine

Group A; Group C

Tadalafil 5 mg DRUG

get 5 mg oral tadalafil for 8 weeks

Group B; Group C

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: only male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naive ( not previously treated) male patient with mild to moderate ED according to SHIM Questionnaire.

You may not qualify if:

• ● Kidney disease or liver failure
• Coronary heart disease
• Peyronie's disease
• Neurological disease that may related to ED

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Mohamed Mahmoud Dogha

Al Fayyum, Keman Fares, 63514, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Arginine; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Model Details: Group (1) was given daily 3 g(three divided doses) oral tablets of L-arginine for eight weeks. Group (2) was given daily 5 mg oral tablets of Tadalafil for eight weeks. Group (3) was given daily 3 g oral tablets of L-arginine and 5 mg oral tablets of Tadalafil for eight weeks.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: January 14, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

EG (1)