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.
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 treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
272
National Taiwan University Hospital
Taipei, Taiwan
Changes in total International Prostate Symptom Scores (I-PSS)
Changes in total International Prostate Symptom Scores (I-PSS)
Time frame: 12 weeks
Changes in I-PSS subscores
Changes in I-PSS subscores
Time frame: 12 weeks
Changes in I-PSS quality of life index
Changes in I-PSS quality of life index
Time frame: 12 weels
Changes in urinary peak flow rate
Changes in urinary peak flow rate
Time frame: 12 weeks
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Time frame: 12 weeks
Incidence of withdrawals due to treatment-emergent adverse events
Incidence of withdrawals due to treatment-emergent adverse events
Time frame: 12 weeks
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