NCT05227508

The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)

A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Se-cure Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BRIZO	A capsule containing 400 mg. SC012 (unique soy extract)
OTHER	placebo	Comprecel microcrystalline cellulose

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-01-01
• Completion: 2024-06-01
• First posted: 2022-02-07
• Last updated: 2022-07-12

Locations

1 site across 1 country: Israel