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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
BRIZO
placebo
Sponsored by
Se-cure Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabin Medical Center - Clalit Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brizo SC012

PLACEBO

Arm Description

A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.

A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.

Outcomes

Primary Outcome Measures

Improved index in the IPSS test
Improvement by 3 points and with a significance of P< 0.05.

Secondary Outcome Measures

Improve UROFLOWMETRY test
Improve from personal baseline in UROFLOWMETRY test at Week 12 .

Full Information

First Posted
January 26, 2022
Last Updated
July 10, 2022
Sponsor
Se-cure Pharmaceuticals Ltd.
Collaborators
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT05227508
Brief Title
The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)
Official Title
A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Se-cure Pharmaceuticals Ltd.
Collaborators
Clalit Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients) Duration - 12 weeks with 3 visits: 0,6,12 weeks 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. dosage: 1 capsule twice daily (morning & evening) can be taken with or without food

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study arm- min. 80 patients Placebo arm- min. 40 patients
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brizo SC012
Arm Type
Experimental
Arm Description
A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.
Intervention Type
Dietary Supplement
Intervention Name(s)
BRIZO
Intervention Description
A capsule containing 400 mg. SC012 (unique soy extract)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Comprecel microcrystalline cellulose
Primary Outcome Measure Information:
Title
Improved index in the IPSS test
Description
Improvement by 3 points and with a significance of P< 0.05.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improve UROFLOWMETRY test
Description
Improve from personal baseline in UROFLOWMETRY test at Week 12 .
Time Frame
12 WEEKS

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohad Shoshani, MD
Phone
+972-54-9577567
Email
ohadsh10@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Raz
Phone
+972-52-7390972
Email
adi@se-curepharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ohad Shoshani, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center - Clalit Health Services
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ohad Shoshany, MD
Phone
+972-54-9577567
Email
ohadsh10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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