L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

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.

NCT Number	NCT07642505
Lead Sponsor	Beni-Suef University
Conditions	Erectile Dysfunction
Enrollment	133 participants
Start Date	2026-06-08
Primary Completion	2026-11 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-12