RECRUITING

The Effects of a Nitrate Supplementation on Erectile Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

To Determine the Potentiating Effects of Berkeley Life Foundation Nitric Oxide Capsules in Supporting Healthy Sexual Function in Men on an Existing Treatment Plan But Who Are Experiencing Occasional Unsatisfactory Erections.

Quick Facts

Study Start:2023-12-12
Study Completion:2024-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06213077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects Male between the ages of 40 and 65
  2. * 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.
  3. * Patients who are able to sign informed consent.
  1. * 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).
  2. * Patients with any known allergy to ingredients of capsule.
  3. * Patients currently taking organic nitrates for acute angina
  4. * Patients who do not or cannot tolerate PDE5 inhibitors
  5. * Patients are unwilling or unable to provide informed consent.

Contacts and Locations

Study Contact

Rebecca Holland, MD
CONTACT
3476326963
rebecca@berkeleylife.com
Trish Lally
CONTACT
00353 86 8735603
trish.lally@lifes2good.com

Principal Investigator

Steven Bauer
PRINCIPAL_INVESTIGATOR
Onsite Clinical Solutions

Study Locations (Sites)

OnSite Clinical Solutions
Charlotte, North Carolina, 28277
United States

Collaborators and Investigators

Sponsor: RHA Investments Ltd

  • Steven Bauer, PRINCIPAL_INVESTIGATOR, Onsite Clinical Solutions

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2024-05-30

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2024-05-30

Terms related to this study

Keywords Provided by Researchers

  • Erectile Dysfunction
  • Nitric Oxide

Additional Relevant MeSH Terms

  • Erectile Dysfunction