Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MCS-2

Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Group Type ACTIVE_COMPARATOR

MCS-2

Intervention Type DRUG

30 mg/day (two 15 mg capsules) Qd for 12 weeks

Placebo

Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 soft-gel placebo capsules Qd for 12 weeks

Interventions

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MCS-2

30 mg/day (two 15 mg capsules) Qd for 12 weeks

Intervention Type DRUG

Placebo

2 soft-gel placebo capsules Qd for 12 weeks

Intervention Type DRUG

Other Intervention Names

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MUS MCS Matching Placebo

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No