A multicenter, prospective clinical trial was performed to study efficacy and tolerance of a compound drug PRO 160/120 in the elderly men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). A total of 257 patients were randomized into two groups. Group 1 of 129 patients received PRO 160/120; group 2 of 128 patients received placebo. In 2-week induction blind phase of placebo the patients received for 24 weeks 1 capsule of the drug or placebo twice a day in conditions of double blind study. The double blind phase was followed by an open control period for 24 weeks when all the patients received PRO 160/120. Treatment efficacy evaluation was based on I-PSS, quality of life index, urodynamic and ultrasonography evidence. PRO 160/120 was superior to placebo by attenuating LUTS assessed by I-PSS, improved obstructive and irritative symptoms, was effective in patients with moderate and severe symptoms. Tolerance of the plant extract was good.