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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initial, 2 months post first arm, 2 months post second arm

Awards & highlights

Study Summary

This trial will recruit 20 individuals from Ballantyne Medical Associates in Charlotte, NC, who have no significant medical conditions. These individuals will be general patients who meet the criteria for the study. Dr

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initial, 2 months post first arm, 2 months post second arm

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Erection Hardness Score

International Index of Erectile Function

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

RHA Investments LtdLead Sponsor

Steven BauerPrincipal InvestigatorOnsite Clinical Solutions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this research study limited to individuals who are above 30 years old?

"This clinical trial is seeking to enroll individuals who are between the ages of 40 and 65 years old."

Answered by AI

What is the upper limit on the number of participants engaged in this clinical investigation?

"Indeed, the information on clinicaltrials.gov confirms that this study is actively seeking eligible participants. The trial was first posted on December 12, 2023 and most recently updated on January 16, 2024. Researchers aim to recruit a total of 20 patients from one designated site."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible candidates. The trial was originally posted on December 12th, 2023 and recently updated on January 16th, 2024. It aims to enroll a total of 20 patients from one specified location."

Answered by AI

Is it possible for me to enroll as a participant in this clinical trial?

"To be eligible for this clinical trial, individuals must have a medical diagnosis of erectile dysfunction and fall within the age range of 40 to 65 years. The study is limited to accepting a total of 20 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of a Nitrate Supplementation on Erectile Function

2023. "The Effects of a Nitrate Supplementation on Erectile Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06213077.

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