MCS in the Treatment of Lower Urinary Tract Symptoms

An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002417

Acronym

MCS_LUTS

Enrollment

274

Registered

2009-10-27

Start date

2010-07-31

Completion date

2014-02-28

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Keywords

Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores

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 Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2. Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Interventions

DRUGMCS-2 15 mg/day

One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.

DRUGMCS-2 30 mg/day

Two MCS-2 soft-gel capsules, oral daily for 12 weeks.

DRUGPlacebo

Two matching placebo soft-gel capsules, oral daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes from baseline in International Prostate Symptom Scores	12 weeks

Secondary

Measure	Time frame
Changes in I-PSS subscores	12 weeks
Changes in I-PSS QOL index	12 weeks
Changes in urine flow rate	12 weels
Incidence of treatment-emergent adverse events (TEAE)	12 weeks
Incidence of withdrawals due to TEAEs	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026