Skip to main content
OpenTrials
Completed

NCT Number: NCT01002222

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MCS-2

Drug

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.

Other names: MUS

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAE)

    Time frame: 36 weeks

Secondary outcomes

  1. Changes from baseline in International Prostate Symptom Score (I-PSS)

    Time frame: 36 weeks

  2. Changes from baseline in urine flow rate

    Time frame: 36 weeks

  3. Changes from baseline in serum lycopene levels

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Health Ever Bio-Tech Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: MCS-2-US-c

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2009
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.