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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Criteria

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.