Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Phase 3
Completed
- Conditions
- Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT01002274
- Lead Sponsor
- Health Ever Bio-Tech Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 180
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MCS-2 MCS-2 2 soft-gel capsules Qd for 40 weeks
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 40 weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline in International Prostate Symptom Scores (I-PSS) 40 weeks
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan