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The Effects of a Nitrate Supplementation on Erectile Function

NCT06213077 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-19

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nitric Oxide

Naturally produced and found in many different kinds of cells and organ systems, NO is an integral molecule in regulating blood pressure and maintaining a healthy cardiovascular system. NO produced or generated in the vasculature then diffuses into the underlying smooth muscle causing these muscles to relax. This results in vasodilation, causing a reduction in systemic blood pressure and an increase in blood flow and oxygen delivery to specific vascular beds.

DRUG

Tadalafil

Vasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension).

OTHER

Placebo

Nitric Oxide Placebo Compound

Sponsors & Collaborators

  • RHA Investments Ltd

    lead INDUSTRY

Principal Investigators

  • Steven Bauer · Onsite Clinical Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-04-30
Completion
2024-05-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06213077 on ClinicalTrials.gov