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

Study Overview
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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.

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.

Official Title
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A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: MCS-2
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MCS-2<br>Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks | Drug: MCS-2<br>* 30 mg/day (two 15 mg capsules) Qd for 12 weeks<br>* Other names: MUS;|
| Placebo Comparator: Placebo<br>Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks | Drug: Placebo<br>* 2 soft-gel placebo capsules Qd for 12 weeks<br>* Other names: MCS Matching Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total International Prostate Symptom Scores (I-PSS) | Changes in total International Prostate Symptom Scores (I-PSS) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in I-PSS subscores | Changes in I-PSS subscores | 12 weeks | 
| Changes in I-PSS quality of life index | Changes in I-PSS quality of life index | 12 weels | 
| Changes in urinary peak flow rate | Changes in urinary peak flow rate | 12 weeks | 
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events | 12 weeks | 
| Incidence of withdrawals due to treatment-emergent adverse events | Incidence of withdrawals due to treatment-emergent adverse events | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores