Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.

Inclusion Criteria:

• Age ≧ 40 years old.
• Not being treated for BPH or LUTS.
• PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer.
• I-PSS ≥ 10
• No known malignancy
• AST/ALT ≦ 3X UNL.
• Creatinine ≦ 3X UNL.
• Subjects who sign the informed consent form.

Exclusion Criteria:

• Subjects' LUTS are not BPH-related
• Have been treated with pelvis irradiation or pelvic surgery.
• Plan to undergo any invasive procedures within the study period.
• Active infection or inflammation.
• Considered ineligible by the investigators.