Health TrialsbyHealthPanel

L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction

ConditionErectile Dysfunction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age30-70
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-Citrulline

    Drug

    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

    Drug

    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

    Drug

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

  • Tadalafil Placebo

    Drug

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

Treatment groups

133 Participants
are divided into 3 treatment groups
Group A: L-CitrullineExperimental treatment 2 interventions
Group B: TadalafilActive comparator 2 interventions
Group C: L-Citrulline Plus TadalafilExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in International Index of Erectile Function-Erectile Function Domain Score

Change in the International Index of Erectile Function-Erectile Function domain score from baseline to week 12. The Erectile Function domain score ranges from 1 to 30, with higher scores indicating better erectile function. A greater positive change indicates greater improvement in erectile function

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Change in International Index of Erectile Function-5 Score

Change in the International Index of Erectile Function-5 score, also known as the Sexual Health Inventory for Men score, from baseline to week 12. The score ranges from 5 to 25, with higher scores indicating better erectile function. A greater positive change indicates greater improvement.

Time frame
Baseline to 12 weeks
2

Treatment Adherence

Percentage of prescribed study medication doses taken during the 12-week treatment period, assessed by patient report and treatment accountability at follow-up visits. Higher percentages indicate better adherence

Time frame
From treatment initiation to 12 weeks
3

Proportion of Participants Achieving Erection Hardness Score Grade 4

Percentage of participants achieving Erection Hardness Score grade 4 at week 12. Grade 4 indicates that the penis is completely hard and fully rigid.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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