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

Health Ever Bio-Tech Co., Ltd.180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Interventions

MCS-2DRUG

2 soft-gel capsules Qd for 40 weeks

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a. * Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study. Exclusion Criteria: * Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a. * Subject is considered ineligible for the study by the investigator(s).

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

Time frame: 40 weeks

Secondary Outcomes

Changes from baseline in International Prostate Symptom Scores (I-PSS)

Time frame: 40 weeks

Data from ClinicalTrials.gov

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