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

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).