Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsPhase 3BENIPRONCT06546735
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
A Phase 3 study testing N0728 and Vesomni® in people with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- What is being tested?
- N0728 and Vesomni®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2026to 30 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to confirm voluntary participation and agree to all purposes of the trial by signing and dating the Informed Consent Form in two copies.
- Men ≥40 years of age.
- History of overactive bladder symptoms (urinary frequency and urgency with or without urinary incontinence) and LUTS for at least 3 months due to BPH.
- History of urinary symptoms (≥1 urgency/24-hour episode and ≥8 urination/24-hour) for at least 3 months prior to screening.
Who cannot join
- Participant who has received mirabegrone or antimuscarinics for the treatment of LUTS within the last 30 days prior to the Screening Visit.
- Participant with evidence of lower urinary tract infection (UTI), confirmed by a culture >100,000 CFU/mL. Should a participant present with a UTI at screening, they may be screened again after successful UTI treatment (confirmed by negative urine culture).
- Participant with symptomatic UTI, prostatitis, or chronic inflammation (such as interstitial cystitis, bladder stones, prior pelvic radiation therapy, or previous or current malignancy within the boundaries of the pelvis, including bladder, prostate, and rectum).
- History of recurrent UTI (2 episodes in the last 6 months or 3 episodes in the last year).
- Participant who has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.).
- Participant with a previous diagnosis of diabetic neuropathy.
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- History of previous open, robotic, or minimally invasive prostate surgery (including transurethral procedures), or reconstructive bladder surgery.
- Participant with planned pelvic or prostate surgery during the trial period.
- Participant with planned cataract or glaucoma surgery during the trial period.
- Participant with significant stress incontinence or post-surgical prostate incontinence as determined by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lais Kurotobi contact
Brazil1 site
Eurofarma Laboratorios S.A
São Paulo, São Paulo, 06696-00
Camila Albuquerque, 5511940204174, camila.albuquerque@eurofarma.com
About this study
Official title: Randomized, Double-blind, Double-masked, Parallel-group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia.
The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages, such as better adherence to treatment. The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists.
Read the detailed description
This is a phase 3, prospective, randomized, multicenter, double-blind, double-masked, parallel group clinical trial to evaluate the efficacy and safety of the fixed-dose combination (FDC) of (N0728) in the treatment of men with moderate to severe storage symptoms (urgency, increased urinary frequency, urge urinary incontinence) and emptying symptoms (weak urine stream, straining or hesitation in urination, sensation of incomplete urination, terminal drip), associated with benign prostatic hyperplasia (BPH).
The trial will have a total duration of a maximum of 130 days (approximately 18 weeks): up to 6 weeks of screening and 12 weeks (± 4 days) of treatment. Potential participants will be screened at Visit -1. Participants who are currently using alpha-blockers will be required to discontinue their current treatment and undergo a run-in period of at least 4 weeks (+2 weeks), thus ensuring the homogeneity of the population at the entry of the trial. All participants will have up to 2 weeks to perform the planned laboratory and imaging tests. At the randomization visit (RV), if eligible, participants will be randomized in a 1:1 ratio and begin trial treatment in a double-blind manner. During the treatment period, participants will return to the study site for two intermediary visits (Visit 1 and 2), and after completing 12 weeks of treatment participants are expected to return for the Final Visit (FV).
- Being tested
- N0728, Vesomni®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N0728Drug
1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®.
Vesomni®Drug
1 tablet of the comparator drug Vesomni® and 1 tablet of the placebo of the test drug.
| Study group | Role | What they receive |
|---|---|---|
| N0728 | Experimental | in the test group will be required to take 1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®. 2 tablets a day, in the morning, after feeding for 84 days. Receives: Drug: N0728 |
| Vesomni® | Active comparator | in the control group will be required to take 1 tablet of Vesomni® and 1 tablet of the placebo of the test drug. 2 tablets a day, in the morning, after feeding for 84 days. Receives: Drug: Vesomni® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of urgency episodes per day
Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of urgency episodes per day, based on the 3-day voiding diary.
Measured: 12 weeks
Secondary outcomes (2)
The mean number of voids per day
Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of voids per day, based on the 3-day voiding diary.
Measured: 12 weeks
The mean number of incontinence episodes per day
Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of incontinence episodes per day, based on the 3-day voiding diary.
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 posted9 Aug 2024
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test Group: N0728 - each participant should take 2 tablets a day, in the morning, after feeding. In a blinded manner, participants in the test group will be required to take 1 tablet of the test drug (N0728) and 1 tablet of placebo of alpha-adrenergic antagonists. Comparator Group: alpha-adrenergic antagonists - Participants in the control group will be required to take 1 tablet of the comparator drug (alpha-adrenergic antagonists) and 1 tablet of the placebo of the test drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546735
- Sponsor's protocol ID
- EF185
- Acronym
- BENIPRO
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-masked, Parallel-group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia.
- ClinicalTrials.gov ID
- NCT06546735
- Acronym / sponsor ID
- BENIPRO / EF185
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 816 participants (estimated)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 9 Aug 2024 (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.
The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages, such as better adherence to treatment. The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists.
Detailed description
This is a phase 3, prospective, randomized, multicenter, double-blind, double-masked, parallel group clinical trial to evaluate the efficacy and safety of the fixed-dose combination (FDC) of (N0728) in the treatment of men with moderate to severe storage symptoms (urgency, increased urinary frequency, urge urinary incontinence) and emptying symptoms (weak urine stream, straining or hesitation in urination, sensation of incomplete urination, terminal drip), associated with benign prostatic hyperplasia (BPH).
The trial will have a total duration of a maximum of 130 days (approximately 18 weeks): up to 6 weeks of screening and 12 weeks (± 4 days) of treatment. Potential participants will be screened at Visit -1. Participants who are currently using alpha-blockers will be required to discontinue their current treatment and undergo a run-in period of at least 4 weeks (+2 weeks), thus ensuring the homogeneity of the population at the entry of the trial. All participants will have up to 2 weeks to perform the planned laboratory and imaging tests. At the randomization visit (RV), if eligible, participants will be randomized in a 1:1 ratio and begin trial treatment in a double-blind manner. During the treatment period, participants will return to the study site for two intermediary visits (Visit 1 and 2), and after completing 12 weeks of treatment participants are expected to return for the Final Visit (FV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Test Group: N0728 - each participant should take 2 tablets a day, in the morning, after feeding. In a blinded manner, participants in the test group will be required to take 1 tablet of the test drug (N0728) and 1 tablet of placebo of alpha-adrenergic antagonists. Comparator Group: alpha-adrenergic antagonists - Participants in the control group will be required to take 1 tablet of the comparator drug (alpha-adrenergic antagonists) and 1 tablet of the placebo of the test drug.
| Arm | Type | Receives |
|---|---|---|
| N0728 | Experimental | Drug: N0728in the test group will be required to take 1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®. 2 tablets a day, in the morning, after feeding for 84 days. |
| Vesomni® | Active comparator | Drug: Vesomni®in the control group will be required to take 1 tablet of Vesomni® and 1 tablet of the placebo of the test drug. 2 tablets a day, in the morning, after feeding for 84 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to confirm voluntary participation and agree to all purposes of the trial by signing and dating the Informed Consent Form in two copies.
- Men ≥40 years of age.
- History of overactive bladder symptoms (urinary frequency and urgency with or without urinary incontinence) and LUTS for at least 3 months due to BPH.
- History of urinary symptoms (≥1 urgency/24-hour episode and ≥8 urination/24-hour) for at least 3 months prior to screening.
Key exclusion criteria (10 listed)
- Participant who has received mirabegrone or antimuscarinics for the treatment of LUTS within the last 30 days prior to the Screening Visit.
- Participant with evidence of lower urinary tract infection (UTI), confirmed by a culture >100,000 CFU/mL. Should a participant present with a UTI at screening, they may be screened again after successful UTI treatment (confirmed by negative urine culture).
- Participant with symptomatic UTI, prostatitis, or chronic inflammation (such as interstitial cystitis, bladder stones, prior pelvic radiation therapy, or previous or current malignancy within the boundaries of the pelvis, including bladder, prostate, and rectum).
- History of recurrent UTI (2 episodes in the last 6 months or 3 episodes in the last year).
- Participant who has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.).
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 |
|---|---|---|
| N07281 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®. | Drug | N0728 |
| Vesomni®1 tablet of the comparator drug Vesomni® and 1 tablet of the placebo of the test drug. | Drug | Vesomni® |
Primary outcome
The mean number of urgency episodes per day
Time frame: 12 weeks
Change from baseline (RV) to the end of 12 weeks of treatment (FV) in the mean number of urgency episodes per day, based on the 3-day voiding diary.
2 secondary outcomes
The mean number of voids per day
Time frame: 12 weeks
The mean number of incontinence episodes per day
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lais Kurotobi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N0728 and Vesomni® in people with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camila Albuquerque (+5511940204174, camila.albuquerque@eurofarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of urgency episodes per day (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 26 Oct 2026.