What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction that enhance nitric oxide production, such as PDE-5 inhibitors (sildenafil, tadalafil, vardenafil), can cause side effects including headaches, flushing, nasal congestion, indigestion, dizziness, and visual disturbances. More serious but less common side effects include hearing loss, priapism (prolonged and painful erection), and cardiovascular events, particularly in patients with preexisting heart conditions. Patients should consult their doctor to ensure these medications are safe for their specific health profile.

What prior FDA approvals exist?

The FDA has approved several phosphodiesterase-5 (PDE-5) inhibitors for the treatment of erectile dysfunction, which enhance nitric oxide production to improve blood flow to the penis. These include sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra). These medications work by inhibiting the PDE-5 enzyme, thereby increasing the levels of nitric oxide and cyclic guanosine monophosphate (cGMP), which relaxes smooth muscle and allows for increased blood flow.

What other types of research exist?

Promising novel alternatives to Berkeley Life capsules for enhancing nitric oxide production in Erectile Dysfunction patients include: <ol> <li>Sildenafil and Vardenafil: These PDE-5 inhibitors have shown efficacy in improving erectile function by enhancing nitric oxide signaling.</li> <li>Extracorporeal Shockwave Therapy (ESWT): This non-invasive treatment has shown potential in improving erectile function by promoting vascularization and nitric oxide production.</li> <li>Acupuncture: Some studies suggest that acupuncture may improve erectile function, potentially through mechanisms involving nitric oxide.</li> <li>Phytotherapies: Certain herbal supplements like cernilton (pollen extract) and quercetin (bioflavonoid) have shown potential benefits in improving symptoms related to erectile dysfunction.</li> </ol>

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Dietary Supplement

The Effects of a Nitrate Supplementation on Erectile Function

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 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

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

0 / 3Eligibility criteria met

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.