Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
Completed · Not applicable
Conditions studied: BPH, Lower Urinary Tract Symptoms
In brief
This study will evaluate LycoComfort™ supplementation in alleviating symptoms associated with LUTS, BPH, and general prostate concerns. Inflammation, oxidative stress and androgenic activity in the prostate are proven catalysts of BPH, ultimately leading to increased prostate cell proliferation. The once-daily supplement LycoComfort™, will be under investigation for symptom relief and will be taken by participants for a duration of 12 weeks.
Key facts
- Study ID
- NCT03772808
- Run by
- LycoRed Ltd.
- People needed
- 52
- Starts
- 2018-11-16
- Expected to finish
- 2019-06-15
- Last updated by the study team
- 2019-07-02
Who can join
Age: 40 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males, age 40 and older
- A score of 8 or greater on a self-administered I-PSS test
You may not qualify if…
- Acute or chronic prostatitis
- Acute urinary retention
- Allergy or sensitivity to any of the test product components (tomato [lycopene] or beta-sitosterol)
- Cancer of the prostate (PCa) or other cancers, current or a history of PCa
- Chronic diseases of the kidneys and/or liver
- Hematuria of unknown etiology
- Infection or malfunction of the urinary tract
- Inflammatory diseases of the urogenital tract
- Medication, herbal supplementation or other substance use for the treatment of urinary symptoms, BPH/LUTS, or erectile dysfunction, including medications which may affect hormonal status within 30 days before screening. These may include, but are not limited to: Sildenafil/Viagra; Tadalafil/Cialis; Vardenafil/Levitra; "Herbal Viagra"; Alpha-Blockers; Oral Steroids, Spironolactone or Testosterone
- Previous radiotherapy of prostate
- Previous surgery of the prostate, bladder or urethra
Where it is running
- Obvio Health — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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