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Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO) | Clinical Trials | Clareo Health

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Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)

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.

NCT06546735•Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

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). 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 116 days (approximately 16 weeks): up to 4 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 undergo a period of 2 weeks of washout, 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).

Eligibility

Age

40 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.

Locations (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil

Key Dates

Start Date

November 30, 2026

Primary Completion Date

April 30, 2028

Completion Date

August 30, 2028

Last Updated

November 15, 2024

Enrollment

816

ESTIMATED participants

Conditions

Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms

Interventions

N0728

DRUG

Vesomni®

DRUG

Contacts

Gleyce Lima

CONTACT

+55115090-8411 gleyce.lima@eurofarma.com

Luiza Terranova

CONTACT

+55115090-8421 luiza.terranova@eurofarma.com

A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia

NCT07146386

Benign Prostatic HyperplasiaBenign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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