New treatment option for Erectile Dysfunction
Official title L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction
ClinicalTrials.gov ID: NCT07642505
What this study is testing
What is L-Citrulline?
L-Citrulline is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for erectile dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70, men only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- Participation in another clinical trial during the previous 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Beni Suweif Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Beni Suweif Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.