Status:
COMPLETED
Effects of LycoComfort™ Supplementation on Symptoms Associated With Lower Urinary Tract Symptoms (LUTS)
Lead Sponsor:
LycoRed Ltd.
Conditions:
BPH
Lower Urinary Tract Symptoms
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
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 p...
Detailed Description
LycoComfort™ is a dietary supplement containing tomato extract and phytosterols, ingredients that have been associated with relief of symptoms associated with general prostate discomfort and Lower Uri...
Eligibility Criteria
Inclusion
- Males, age 40 and older
- A score of 8 or greater on a self-administered I-PSS test
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03772808
Start Date
November 16 2018
End Date
June 15 2019
Last Update
July 2 2019
Active Locations (1)
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1
Obvio Health
Orlando, Florida, United States, 32817