BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)NCT05227508
The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)
A study testing BRIZO in people with BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS), run by Se-cure Pharmaceuticals Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- BRIZO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center - Clalit Health Services
Petah Tikva, 4941492
Ohad Shoshany, MD, +972-54-9577567, ohadsh10@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- BRIZO, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIZODietary supplement
A capsule containing 400 mg. SC012 (unique soy extract)
placeboOther
Comprecel microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Brizo SC012 | Experimental | A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING. Receives: Dietary Supplement: BRIZO |
| PLACEBO | Placebo comparator | A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved index in the IPSS test
Improvement by 3 points and with a significance of P< 0.05.
Measured: 12 weeks
Secondary outcomes (1)
Improve UROFLOWMETRY test
Improve from personal baseline in UROFLOWMETRY test at Week 12 .
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startAug 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Study arm- min. 80 patients * Placebo arm- min. 40 patients
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Se-cure Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Ohad Shoshani, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227508
- Sponsor's protocol ID
- 0615-21-RMC
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05227508
- Acronym / sponsor ID
- 0615-21-RMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Se-cure Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clalit Health Services
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- * Study arm- min. 80 patients * Placebo arm- min. 40 patients
| Arm | Type | Receives |
|---|---|---|
| Brizo SC012 | Experimental | Dietary Supplement: BRIZOA capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING. |
| PLACEBO | Placebo comparator | Other: placeboA capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIZOA capsule containing 400 mg. SC012 (unique soy extract) | Dietary supplement | Brizo SC012 |
| placeboComprecel microcrystalline cellulose | Other | PLACEBO |
Primary outcome
Improved index in the IPSS test
Time frame: 12 weeks
Improvement by 3 points and with a significance of P< 0.05.
1 secondary outcome
Improve UROFLOWMETRY test
Time frame: 12 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ohad Shoshani, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIZO in people with BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS), run by Se-cure Pharmaceuticals Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ohad Shoshani, MD (+972-54-9577567, ohadsh10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved index in the IPSS test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.