PERLESPERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Fecha de inicio: 1 de abril de 2014

Inclusion Criteria: * Male subject * Between 45 and 85 years old * Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream * Subject naive to any prior treatment for LUTS due to BPH * Prostate enlargement at digital rectal examination (DRE) suggestive of BPH * I-PSS \> 12 at enrolment visit and at inclusion visit * QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit Exclusion Criteria: * Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra) * Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle * Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus * Known severe renal insufficiency or creatinine clearance \< 30 ml/mn * Known liver insufficiency or clinically significant abnormal liver function tests * History of, or concomitant, cardiac arrhythmia or angina pectoris * Orthostatic hypotension at enrolment or inclusion visit * Known hypersensitivity to one of the constituents of the study drugs * Is participating in another clinical trial