NCT01002274

Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Open-Label, 40-weeks 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: 180 (actual)
• 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-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-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 same daily dosage as the active treatment given under the protocol MCS-2-TWN-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	2 soft-gel capsules Qd for 40 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2009-10-27
• Last updated: 2016-11-11

Locations

1 site across 1 country: Taiwan