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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: N0728; Drug: Vesomni®

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).

• Study Type: Interventional
• Enrollment (Estimated): 816
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gleyce Lima; Phone Number: +55115090-8411; Email: gleyce.lima@eurofarma.com
• Study Contact Backup: Name: Luiza Terranova; Phone Number: +55115090-8421; Email: luiza.terranova@eurofarma.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 06696-00
      • Eurofarma Laboratórios S.A
      • Contact: Gleyce Lima; Phone Number: 551150908411; Email: gleyce.lima@eurofarma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N0728; 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.	Drug: N0728; 1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®.
Active Comparator: 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.	Drug: Vesomni®; 1 tablet of the comparator drug Vesomni® and 1 tablet of the placebo of the test drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: EF185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No