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L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction
Sponsor: Beni-Suef University
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.
Official title: L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized Trial
Key Details
Gender
MALE
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
133
Start Date
2026-06-08
Completion Date
2026-12
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
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.
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.
L-Citrulline Placebo
Oral placebo preparation matching L-citrulline, administered for 12 weeks as part of the double-dummy design
Tadalafil Placebo
Oral placebo preparation matching tadalafil, administered for 12 weeks as part of the double-dummy study design.
Locations (1)
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt