L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, three-arm, active-controlled trial will compare daily L-citrulline, daily tadalafil, and the combination of both in men aged 30–70 with mild to moderate erectile dysfunction. Participants are treated for 12 weeks with assessments at baseline, week 4, week 8, and week 12, including validated erectile function questionnaires and safety monitoring. The primary outcome is the change in the erectile function domain of the International Index of Erectile Function (IIEF-EF) from baseline to week 12, with secondary outcomes covering IIEF-5/SHIM, Erection Hardness Score, SEP-3 responses, adherence, and adverse events. The study is conducted at the Urology outpatient clinics of Beni-Suef University in Egypt, using double-blind and double-dummy methods where feasible.

Why it matters

Who can join: the full rules

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 stroke, uncontrolled hypertension, or high-risk arrhythmia.
* Severe hepatic impairment.
* Severe renal impairment.
* Untreated hypogonadism requiring hormonal treatment.
* Hyperprolactinemia or uncontrolled endocrine disorder.
* Major neurogenic erectile dysfunction, spinal cord injury, or previous radical pelvic surgery causing severe erectile dysfunction.
* Significant Peyronie's disease preventing intercourse.
* Active major psychiatric illness impairing reliable assessment.
* Use of phosphodiesterase type 5 inhibitors, intracavernosal injection therapy, vacuum device therapy, testosterone therapy, L-arginine, L-citrulline, or erectile dysfunction nutraceuticals during the washout period before randomization.
* Participation in another clinical trial during the previous 3 months.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy — Faculty of medicine Beni-Suef University
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.