The Effects of a Nitrate Supplementation on Erectile Function (NCT06213077) | Clinical Trial Compass
UnknownNot Applicable
The Effects of a Nitrate Supplementation on Erectile Function
United States20 participantsStarted 2023-12-12
Plain-language summary
Twenty (20) individuals to be recruited from Ballantyne Medical Associates in Charlotte, NC, without any significant chronic medical history. These patients are general patients for primary care that meet inclusion criteria. Patients will be screened and enrolled by Dr. Bauer and his delegated research staff upon patient consult. Patients will be informed of the purpose of the study including risks, benefits, and alternative treatments to the study. After the potential participants have been given the opportunity to ask questions and have their questions answered, they will be asked to sign an informed consent prior to any study-specific procedures being performed.
Blinded test product will be randomly assigned to study subjects. Test group 1 will be dosed with a placebo capsule taken two capsules once daily Test group 2 will be dosed with Berkeley Life capsules taken two capsules once daily. At baseline, prior to crossover to the other treatment, and at the study's conclusion, NO levels will be monitored using salivary nitric oxide test strips. Both test groups will remain on their existing treatment protocol throughout the study.
Who can participate
Age range
40 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects Male between the ages of 40 and 65
* Subjects looking to support healthy sexual function who have been undergoing treatment to support healthy erections for at least 90 days with unsatisfactory results and whose nitric oxide levels are suboptimal based on an easy-to-use, self-check saliva strip that provides immediate, real-time, actionable feedback.
* Patients who are able to sign informed consent.
Exclusion Criteria:
* Patients who are not considered medically stable (history of drug or alcohol dependency or having experienced health issues which could prevent experiencing a healthy erection).
* Patients with any known allergy to ingredients of capsule.
* Patients currently taking organic nitrates for acute angina
* Patients who do not or cannot tolerate PDE5 inhibitors
* Patients are unwilling or unable to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Index of Erectile Function
Timeframe: Initial, 2 months post first arm, 2 months post second arm
2
Erection Hardness Score
Timeframe: Initial, 2 months post first arm, 2 months post second arm