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A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.
1. Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia. 2. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients) 3. Duration - 12 weeks with 3 visits: 0,6,12 weeks 4. The following procedures are utilized: * Physical exams - visit 1,3. * Drugs/food supplement usage questionnaire - visit 1. * Product supply Control - visit 1,2.3 * Clinical laboratory tests : psa, cbc, bun - visit 1,3. * Uroflowmetry test visit - visit 1,3. * IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3. * IIEF questionnaire - visit 1, 3. 5. dosage: 1 capsule twice daily (morning \& evening) can be taken with or without food
Age
50 - No limit years
Sex
MALE
Healthy Volunteers
No
Rabin Medical Center - Clalit Health Services
Petah Tikva, Israel
Start Date
August 1, 2022
Primary Completion Date
January 1, 2024
Completion Date
June 1, 2024
Last Updated
July 12, 2022
120
ESTIMATED participants
BRIZO
DIETARY_SUPPLEMENT
placebo
OTHER
Lead Sponsor
Se-cure Pharmaceuticals Ltd.
Collaborators
Data Source & Attribution
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