Status:
COMPLETED
Efficacy and Safety of MCS-2 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:
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
Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treat...
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 :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT01002664
Start Date
May 1 2010
End Date
June 1 2014
Last Update
August 2 2018
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10002