Clinical Trial

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

Study acronym: BENIPRO
Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-08; most recent amendment 2024-11-13.
Trial Details
NCT Number NCT06546735
Lead Sponsor Eurofarma Laboratorios S.A.
Conditions Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms
Enrollment 816 participants
Start Date 2026-11-30
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-15