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L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

NCT07642505 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-06-12

No results posted yet for this study

Summary

Erectile dysfunction is a common male sexual health problem that may affect quality of life and sexual relationships. Tadalafil 5 mg once daily is an established oral treatment for erectile dysfunction. L-citrulline is an oral nitric oxide pathway supplement that may improve erectile function by increasing L-arginine availability.

This randomized trial will compare three oral treatment regimens in men with mild to moderate erectile dysfunction: L-citrulline 1500 mg/day, tadalafil 5 mg/day, and the combination of L-citrulline 1500 mg/day plus tadalafil 5 mg/day. Participants will receive treatment for 12 weeks and will be followed at baseline, week 4, week 8, and week 12.

The primary outcome will be the change in the International Index of Erectile Function-Erectile Function domain score from baseline to 12 weeks. Secondary outcomes will include changes in IIEF-5/SHIM score, Erection Hardness Score, SEP diary outcomes, treatment adherence, adverse events, and treatment discontinuation.

Conditions

Interventions

DRUG

L-Citrulline

Oral L-citrulline 1500 mg/day administered for 12 weeks as an active oral nitric oxide pathway supplement for men with mild to moderate erectile dysfunction.

DRUG

Tadalafil

Oral tadalafil 5 mg once daily administered for 12 weeks as active phosphodiesterase type 5 inhibitor therapy for men with mild to moderate erectile dysfunction.

DRUG

L-Citrulline Placebo

Oral placebo preparation matching L-citrulline, administered for 12 weeks as part of the double-dummy design

DRUG

Tadalafil Placebo

Oral placebo preparation matching tadalafil, administered for 12 weeks as part of the double-dummy study design.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Hany F Badawy · Faculty of medicine Beni-Suef University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07642505 on ClinicalTrials.gov