Status:
COMPLETED
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
Lead Sponsor:
Health Ever Bio-Tech Co., Ltd.
Conditions:
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE3
Brief 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 st...
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-...
Eligibility Criteria
Inclusion
- Subject has completed 12 weeks of treatment under the protocol MCS-2-US-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
- Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
- Subject is considered ineligible for the study by the investigator(s).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01002222
Start Date
January 1 2011
End Date
February 1 2014
Last Update
March 3 2015
Active Locations (1)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095