Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)

Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002222

Acronym

MCS-2-US-c

Enrollment

200

Registered

2009-10-27

Start date

2011-01-31

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, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score

Brief summary

This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.

Detailed description

This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Interventions

DRUGMCS-2

15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a. * Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.

Exclusion criteria

* Subject has severe LUTS at the last visit under the protocol MCS-2-US-a. * Subject is considered ineligible for the study by the investigator(s).

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAE)	36 weeks

Secondary

Measure	Time frame
Changes from baseline in International Prostate Symptom Score (I-PSS)	36 weeks
Changes from baseline in urine flow rate	36 weeks
Changes from baseline in serum lycopene levels	36 weeks

Countries

United States

Outcome results

None listed

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