NCT05227508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

January 26, 2022

Last Update Submit

July 10, 2022

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Improved index in the IPSS test

    Improvement by 3 points and with a significance of P\< 0.05.

    12 weeks

Secondary Outcomes (1)

  • Improve UROFLOWMETRY test

    12 WEEKS

Study Arms (2)

Brizo SC012

EXPERIMENTAL

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

Dietary Supplement: BRIZO

PLACEBO

PLACEBO COMPARATOR

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

Other: placebo

Interventions

BRIZODIETARY_SUPPLEMENT

A capsule containing 400 mg. SC012 (unique soy extract)

Brizo SC012
placeboOTHER

Comprecel microcrystalline cellulose

PLACEBO

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center - Clalit Health Services

Petah Tikva, 4941492, Israel

RECRUITING

Study Officials

  • Ohad Shoshani, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ohad Shoshani, MD

CONTACT

+972-54-9577567ohadsh10@gmail.com

Adi Raz

CONTACT

+972-52-7390972adi@se-curepharma.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Study arm- min. 80 patients * Placebo arm- min. 40 patients
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)