Erectile DysfunctionNCT06213077
The Effects of a Nitrate Supplementation on Erectile Function
A study testing Nitric Oxide and Tadalafil in people with Erectile Dysfunction, run by RHA Investments Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Nitric Oxide and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects Male between the ages of 40 and 65
- 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.
- Patients who are able to sign informed consent.
Who cannot join
- 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).
- Patients with any known allergy to ingredients of capsule.
- Patients currently taking organic nitrates for acute angina
- Patients who do not or cannot tolerate PDE5 inhibitors
- Patients are unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
Steven Bauer, MD, 800-785-3150 ext. 131, steve@ballantynemedical.com
Elizabeth Allison, 800-785-3150 ext. 131, contracts@onsiteclinical.com
About this 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.
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.
Read the detailed description
Patients will be consented and enrolled in the study. A complete medical history and focused physical examination will be conducted and documented and NO levels will be measured using salivary test strips.
Twenty (20) patients with low NO levels will be enrolled and will be randomly assigned to group 1 or group 2.
Once enrolled, patients will be required to complete a subjective questionnaire (the International Index of Erectile Function (IIEF)), EHS Score questionnaire and a Quality of Life (QOL) survey. Patients will be instructed to take 2 Berkeley Life capsules once daily or the placebo based on randomization. The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.
Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily in combination with their existing treatment protocol and then return on day 60, returning all unused test product.
The subject should be willing to self-administer 2 capsules daily and be willing to, upon waking in the AM, self-test with strip and record on a pre-print sheet the test strip color, followed by self-administration of capsule(s) and then at 2 hours self-test again and record on a pre-print sheet the test strip color.
Upon the return visit, patients will be crossed over after a 4 week wash out and given the other test group 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.
The remaining product will be collected, and patients released from the study. Data will be collected on Case Report Forms.
- Conditions
- Erectile Dysfunction
- Being tested
- Nitric Oxide, Tadalafil, Placebo
- Keywords
- Erectile Dysfunction, Nitric Oxide
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDietary supplement
Also called Berkeley Life
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.
TadalafilDrug
Vasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension).
PlaceboOther
Nitric Oxide Placebo Compound
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Active comparator | 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 Receives: Dietary Supplement: Nitric Oxide; Drug: Tadalafil |
| Placebo | Placebo comparator | 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 Receives: Drug: Tadalafil; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function
The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction [17]. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.
Measured: Initial, 2 months post first arm, 2 months post second arm
Erection Hardness Score
The Erection Hardness Scale (EHS) involves a 1-4 response to a single question to assess firmness of erection, where 3 is sufficient for penetration and 4 is a rigid erection
Measured: Initial, 2 months post first arm, 2 months post second arm
Secondary outcomes (1)
SF-36 Quality of Life Questionnaire
The 36-Item Short Form Health Survey (SF-36) in 1992. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Measured: Initial, 2 months post first arm, 2 months post second arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start12 Dec 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- IRB approved, double blind placebo-controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RHA Investments Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Bauer, Principal investigator, Onsite Clinical Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213077
- Sponsor's protocol ID
- #EDSupp23
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06213077
- Acronym / sponsor ID
- #EDSupp23
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RHA Investments LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be consented and enrolled in the study. A complete medical history and focused physical examination will be conducted and documented and NO levels will be measured using salivary test strips.
Twenty (20) patients with low NO levels will be enrolled and will be randomly assigned to group 1 or group 2.
Once enrolled, patients will be required to complete a subjective questionnaire (the International Index of Erectile Function (IIEF)), EHS Score questionnaire and a Quality of Life (QOL) survey. Patients will be instructed to take 2 Berkeley Life capsules once daily or the placebo based on randomization. The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.
Patients will be sent home with instructions to take 2 Berkeley Life capsules once daily in combination with their existing treatment protocol and then return on day 60, returning all unused test product.
The subject should be willing to self-administer 2 capsules daily and be willing to, upon waking in the AM, self-test with strip and record on a pre-print sheet the test strip color, followed by self-administration of capsule(s) and then at 2 hours self-test again and record on a pre-print sheet the test strip color.
Upon the return visit, patients will be crossed over after a 4 week wash out and given the other test group 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.
The remaining product will be collected, and patients released from the study. Data will be collected on Case Report Forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- IRB approved, double blind placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Active comparator | Dietary Supplement: Nitric Oxide, Drug: TadalafilUpon 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 |
| Placebo | Placebo comparator | Drug: Tadalafil, Other: PlaceboUpon 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects Male between the ages of 40 and 65
- 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.
- Patients who are able to sign informed consent.
Key exclusion criteria (5 listed)
- 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).
- Patients with any known allergy to ingredients of capsule.
- Patients currently taking organic nitrates for acute angina
- Patients who do not or cannot tolerate PDE5 inhibitors
- Patients are unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: Berkeley LifeNaturally 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. | Dietary supplement | Nitric Oxide |
| TadalafilVasodilator which treats erectile dysfunction and enlarged prostate (benign prostatic hyperplasia). It can also treat high blood pressure in the lungs (pulmonary arterial hypertension). | Drug | Nitric Oxide, Placebo |
| PlaceboNitric Oxide Placebo Compound | Other | Placebo |
Primary outcome
International Index of Erectile Function
Time frame: Initial, 2 months post first arm, 2 months post second arm
The (IIEF) was developed by Rosen and colleagues in 1997 as a multidimensional, 15-item, self-administered questionnaire with the goal of assessing five domains of male sexual function including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction [17]. The erectile function domain of the IIEF (IIEF-EF) contains 6 questions which the patient answers on a scale from 1 (never or almost never) to 5 (almost always or always), providing a total score of 6 to 30 points. The questions concern erectile frequency, firmness, penetration ability, maintenance frequency, maintenance ability, and erection confidence. Based on a controlled study of 1,151 men taking sildenafil in order to establish cutoff scores for the IIEF-EF, a score of 26 or greater is defined as normal function, mild ED is a score from 22 to 25, mild to moderate ED 17 to 21, moderate ED 11 to 16, and severe ED 6 to 10.
Erection Hardness Score
Time frame: Initial, 2 months post first arm, 2 months post second arm
The Erection Hardness Scale (EHS) involves a 1-4 response to a single question to assess firmness of erection, where 3 is sufficient for penetration and 4 is a rigid erection
1 secondary outcome
SF-36 Quality of Life Questionnaire
Time frame: Initial, 2 months post first arm, 2 months post second arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Bauer principal investigator
Onsite Clinical Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitric Oxide and Tadalafil in people with Erectile Dysfunction, run by RHA Investments Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Holland, MD (3476326963, rebecca@berkeleylife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (time frame: Initial, 2 months post first arm, 2 months post second arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.