ProstatismS4S4BPH/EDNCT03681392
Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED
A study testing Dr. Pyke's Supplement for Stream (S4S) in people with Prostatism and Erectile Dysfunction, run by Robert E. Pyke.
Trial summary
This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatism, Erectile Dysfunction
- What is being tested?
- Dr. Pyke's Supplement for Stream (S4S)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to Mar 2023
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men at least 40 years of age
- Screening IPSS QoL must be 4-6:
- If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6)
- Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations
- Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment
- Required for target efficacy subset
- Meets criterion for at least moderate ED: IIEF-5 (erectile function) score <13 - or:
- Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20
Who cannot join
- Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.
- Current severe side effects from any drug
- Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.
- Women
About this study
Official title: A Phase 2 Open-label Randomized Crossover Dose-finding Study of the Efficacy, Safety, and Tolerability of Dr. Pyke's Supplement for Stream (S4S) in Older Men With Lower Urinary Tract Symptoms and/or Sexual Dysfunction
This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.
Read the detailed description
This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion.
- Conditions
- Prostatism, Erectile Dysfunction
- Being tested
- Dr. Pyke's Supplement for Stream (S4S)
- Keywords
- Benign Prostatic Hypertrophy, Erectile Dysfunction, Nutritional Supplements, Prostatism, Lower Urinary Tract Symptoms, male
- Medical subject headings
- Prostatism, Erectile Dysfunction, Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr. Pyke's Supplement for Stream (S4S)Dietary supplement
Also called S4S
Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Once daily then twice daily | Experimental | One 6.5 cc scoop of S4S once a day for 7 days, then one 6.5 cc scoop of S4S twice a day for 7 days Receives: Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S) |
| Twice daily then once daily | Experimental | One 6.5 cc scoop of S4S twice a day for 7 days, then one 6.5 cc scoop of S4S once a day for 7 days Receives: Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
measure of lower urinary tract symptoms in men with prostatism, total score; 0=best possible (no symptoms); 35 = worst possible; mean change and number of patients 50% improved
Measured: 1-4 weeks
Primary safety outcome: adverse events
Reports from subjects of new or worse symptoms; number of patients with any adverse event, count and % of patients with each type of such adverse events
Measured: 1 week
Secondary outcomes (4)
Secondary safety outcome: Adverse event dropouts
Reports from subjects; number and % of patients
Measured: 1-2 weeks
International Prostate Symptoms Scale Quality of Life due to urinary symptoms
categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point
Measured: 1-4 weeks
Volunteer's Global Impression of Change in Erectile function
categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point
Measured: 1 week
International Index of Erectile Function (IIEF)-5
5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Jan 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProstatismStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert E. Pyke
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Robert E. Pyke, drpykessupplements.com
- Investigators
- Robert E Pyke, MD, PhD, Study director, Pykonsult LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681392
- Sponsor's protocol ID
- Pykonsult 2001
- Acronym
- S4S4BPH/ED
- Status last verified
- Dec 2021
- First submitted
- 20 Sep 2018
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Publications
Pyke RE. Exo-Clinical Trials of Nutritional Supplements for Sexual Dysfunction: Precedents, Principles, and Protocols. Sex Med Rev. 2019 Apr;7(2):251-258. doi: 10.1016/j.sxmr.2018.07.002. Epub 2018 Oct 6.
PubMed 30301704
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Randomized Crossover Dose-finding Study of the Efficacy, Safety, and Tolerability of Dr. Pyke's Supplement for Stream (S4S) in Older Men With Lower Urinary Tract Symptoms and/or Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT03681392
- Acronym / sponsor ID
- S4S4BPH/ED / Pykonsult 2001
- Conditions
- Prostatism, Erectile Dysfunction
- Keywords
- Benign Prostatic Hypertrophy, Erectile Dysfunction, Nutritional Supplements, Prostatism, Lower Urinary Tract Symptoms, male
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Robert E. PykeIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 24 Sep 2018 (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.
This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.
Detailed description
This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily
| Arm | Type | Receives |
|---|---|---|
| Once daily then twice daily | Experimental | Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)One 6.5 cc scoop of S4S once a day for 7 days, then one 6.5 cc scoop of S4S twice a day for 7 days |
| Twice daily then once daily | Experimental | Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)One 6.5 cc scoop of S4S twice a day for 7 days, then one 6.5 cc scoop of S4S once a day for 7 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men at least 40 years of age
- Screening IPSS QoL must be 4-6:
- If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6)
- Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations
- Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment
Key exclusion criteria (4 listed)
- Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.
- Current severe side effects from any drug
- Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.
- Women
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 |
|---|---|---|
| Dr. Pyke's Supplement for Stream (S4S)Also: S4SProprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3 | Dietary supplement | Once daily then twice daily, Twice daily then once daily |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: 1-4 weeks
measure of lower urinary tract symptoms in men with prostatism, total score; 0=best possible (no symptoms); 35 = worst possible; mean change and number of patients 50% improved
Primary safety outcome: adverse events
Time frame: 1 week
Reports from subjects of new or worse symptoms; number of patients with any adverse event, count and % of patients with each type of such adverse events
4 secondary outcomes
Secondary safety outcome: Adverse event dropouts
Time frame: 1-2 weeks
International Prostate Symptoms Scale Quality of Life due to urinary symptoms
Time frame: 1-4 weeks
Volunteer's Global Impression of Change in Erectile function
Time frame: 1 week
International Index of Erectile Function (IIEF)-5
Time frame: 1-4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 30301704Pyke RE. Exo-Clinical Trials of Nutritional Supplements for Sexual Dysfunction: Precedents, Principles, and Protocols. Sex Med Rev. 2019 Apr;7(2):251-258. doi: 10.1016/j.sxmr.2018.07.002. Epub 2018 Oct 6.
- Individual participant dataSharing planned: Undecided. Yes
Related trials for Prostatism
Recruiting
Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients
Urologic Diseases, Urinary Tract Infections
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.
Robert E Pyke, MD, PhD study director
Pykonsult LLC
Questions about this trial
What is this clinical trial studying?
A study testing Dr. Pyke's Supplement for Stream (S4S) in people with Prostatism and Erectile Dysfunction, run by Robert E. Pyke.
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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: 1-4 weeks). 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?
On the ClinicalTrials.gov record for NCT03681392, which also lists 1 linked publication.
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 20 Dec 2021.