Status:
NOT_YET_RECRUITING
Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms
Eligibility:
MALE
40+ years
Phase:
PHASE3
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 f...
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) i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
816 Patients enrolled
Trial Details
Trial ID
NCT06546735
Start Date
November 30 2026
End Date
August 30 2028
Last Update
November 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil, 06696-00