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

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.

Study Overview

• Status: Recruiting
• Conditions: BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)
• Intervention / Treatment: Dietary supplement: BRIZO; Other: placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ohad Shoshani, MD; Phone Number: +972-54-9577567; Email: ohadsh10@gmail.com
• Study Contact Backup: Name: Adi Raz; Phone Number: +972-52-7390972; Email: adi@se-curepharma.com

Study Locations

• Israel
  • Petach Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center - Clalit Health Services
    • Contact: Ohad Shoshany, MD; Phone Number: +972-54-9577567; Email: ohadsh10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia

Exclusion Criteria:

• Inability to complete the questionnaire.
• Patients with or suspected of having prostate cancer.
• Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH.
• Patients treated with drugs for kidney / urinary tract problems.
• Allergy to soy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brizo SC012; A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.	Dietary supplement: BRIZO; A capsule containing 400 mg. SC012 (unique soy extract)
Placebo Comparator: PLACEBO; A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.	Other: placebo; Comprecel microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved index in the IPSS test	Improvement by 3 points and with a significance of P< 0.05.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve UROFLOWMETRY test	Improve from personal baseline in UROFLOWMETRY test at Week 12 .	12 WEEKS

Collaborators and Investigators

• Sponsor: Se-cure Pharmaceuticals Ltd.
• Collaborators: Clalit Health Services
• Investigators: Principal Investigator: Ohad Shoshani, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 0615-21-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No