NCT01002222

Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)

Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Health Ever Bio-Tech Co., Ltd. · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.

Detailed description

This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Conditions

• Lower Urinary Tract Symptoms
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	MCS-2	15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-10-27
• Last updated: 2015-03-03

Locations

1 site across 1 country: United States