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

NCT06546735 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EF185
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The mean number of voids per day

  12 weeks

• The mean number of incontinence episodes per day

  12 weeks

Study Arms (2)

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.

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.

Drug: Vesomni®

Interventions

N0728 DRUG

1 tablet of the test drug (N0728) and 1 tablet of placebo of Vesomni®.

N0728

Vesomni® DRUG

1 tablet of the comparator drug Vesomni® and 1 tablet of the placebo of the test drug.

Vesomni®

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, 06696-00, Brazil

Location

Central Study Contacts

Gleyce Lima

CONTACT

+55115090-8411; gleyce.lima@eurofarma.com

Luiza Terranova

CONTACT

+55115090-8421; luiza.terranova@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)