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Dietary Supplement

Nitric Oxide for Erectile Dysfunction

N/A
Recruiting
Led By Steven Bauer
Research Sponsored by RHA Investments Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects between the ages of 40 and 65
Be older than 18 years old
Must not have
Patients who do not or cannot tolerate PDE5 inhibitors
Patients currently taking organic nitrates for acute angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial, 2 months post first arm, 2 months post second arm

Summary

This trial is testing Berkeley Life capsules in individuals with low nitric oxide levels. The supplement aims to boost nitric oxide, which can improve blood flow and health outcomes like erectile function and quality of life.

Who is the study for?
This trial is for individuals from Ballantyne Medical Associates in Charlotte, NC, who have erectile dysfunction but no significant chronic medical conditions. Participants must be willing to take capsules daily and provide saliva samples for nitric oxide testing.
What is being tested?
The study tests the effects of a placebo versus Berkeley Life capsules on erectile function by monitoring salivary nitric oxide levels at different stages. Patients will continue their usual treatment while taking either the placebo or the supplement.
What are the potential side effects?
Potential side effects are not detailed in this summary, but participants should discuss risks with Dr. Bauer during consultation. Common side effects may include headache, indigestion, or muscle aches similar to those experienced with Tadalafil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 40 and 65.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take or tolerate PDE5 inhibitor medications.
Select...
I am currently using medication for sudden chest pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial, 2 months post first arm, 2 months post second arm
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial, 2 months post first arm, 2 months post second arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Erection Hardness Score
International Index of Erectile Function
Secondary study objectives
SF-36 Quality of Life Questionnaire

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Nitric OxideActive Control2 Interventions
Upon enrollment, patients will complete the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey. Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily (in this case Active NO), in combination with their existing treatment protocol (Tadalafil) and then return on day 60, returning all unused test product. After 60 days of taking the active ingredient + tadalafil, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey. After a 4 week wash out, patients will be crossed over to the placebo group and given the other combination. After 60 days of both combinations, placebo and active, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey
Group II: PlaceboPlacebo Group2 Interventions
Upon enrollment, patients will complete the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey. Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily (in this case the placebo), in combination with their existing treatment protocol (Tadalafil) and then return on day 60, returning all unused test product. After 60 days of taking the placebo + tadalafil, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey. After a 4 week wash out, patients will be crossed over to the active group and given the other combination. After 60 days of each combination, placebo and active, patients will repeat the IIEF questionnaire, EHS Score questionnaire and the Quality of Life survey

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Erectile Dysfunction (ED) often focus on enhancing nitric oxide (NO) production or inhibiting phosphodiesterase type 5 (PDE-5). Nitric oxide is crucial for initiating and maintaining an erection as it facilitates the relaxation of smooth muscles in the penile arteries, increasing blood flow. Supplements like Berkeley Life capsules aim to boost NO levels, potentially improving erectile function. PDE-5 inhibitors, such as sildenafil (Viagra), work by blocking the enzyme PDE-5, which breaks down cyclic guanosine monophosphate (cGMP), a molecule that promotes muscle relaxation and blood flow. By inhibiting PDE-5, these medications enhance the effects of NO, leading to improved erectile function. These treatments are vital for ED patients as they directly address the physiological mechanisms underlying the condition, thereby improving sexual performance and quality of life.

Find a Location

Who is running the clinical trial?

RHA Investments LtdLead Sponsor
Steven BauerPrincipal InvestigatorOnsite Clinical Solutions
~10 spots leftby Dec 2025