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 a
| Condition(s) | Erectile Dysfunction |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 fr |
| Who can participate | Inclusion Criteria: * Male patients aged 30 to 70 years. * Erectile dysfunction for at least 3 months. * Mild to moderate erectile dysfunction, defined by International Index of Erectile Function-Erectile Function domain score from 11 to 25. * Stable sexual relationship during the study period. * Willingness to attempt sexual activity during the study period. * Ability to complete study questionnaires and attend follow-up visits. * Written informed consent. Exclusion Criteria: * Severe erectile dysfunction, defined by International Index of Erectile Function-Erectile Function domain score of 10 or less. * Current nitrate or nicorandil use. * Contraindication or hypersensitivity to tadalafil or L-citrulline. * Unstable cardiovascular disease, unstable angina, recent myocardial infarction or |
| Ages | 30 Years to 70 Years |
| Sex | Male |
| Lead sponsor | Beni-Suef University |
| Locations | Banī Suwayf, Beni Suweif Governorate, Egypt |
| Start date | 2026-06-08 |
| NCT ID | NCT07642505 |
| Official listing | https://clinicaltrials.gov/study/NCT07642505 |