NCT01002664

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Health Ever Bio-Tech Co., Ltd. · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lower Urinary Tract Symptoms
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	MCS-2	30 mg/day (two 15 mg capsules) Qd for 12 weeks
DRUG	Placebo	2 soft-gel placebo capsules Qd for 12 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2009-10-27
• Last updated: 2018-08-02

Locations

1 site across 1 country: Taiwan