Status:
COMPLETED
MCS in the Treatment of Lower Urinary Tract Symptoms
Lead Sponsor:
Health Ever Bio-Tech Co., Ltd.
Conditions:
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Detailed Description
This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate. Phase 2b Objectiv...
Eligibility Criteria
Inclusion
- Age ≧ 40 years old
- Not being treated for BPH or LUTS
- PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer
- I-PSS ≥ 10
- No known malignancy
- AST/ALT ≦ 3X UNL
- Creatinine ≦ 3X UNL
- Subjects who sign the informed consent form
Exclusion
- Subjects' LUTS are not BPH-related
- Have been treated with pelvis irradiation or pelvic surgery
- Plan to undergo any invasive procedures within the study period
- Active infection or inflammation
- Considered ineligible by the investigators
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT01002417
Start Date
July 1 2010
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