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NCT03681392: S4S4BPH/ED
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
NA trial testing Dr. Pyke's Supplement for Stream (S4S) in Prostatism. Withdrawn.
1 December 2022
Quick facts
| Lead sponsor | Robert E. Pyke |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Start date | 1 January 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 March 2023 |
Drugs / interventions tested
- Dr. Pyke's Supplement for Stream (S4S)
Conditions studied
- Prostatism — all drugs for Prostatism →
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
Robert E. Pyke
Who can join
40 and older, male only, with Prostatism or Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03681392
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03681392 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Robert E. Pyke
- Last refreshed: 4 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03681392.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing