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

This study has been completed.
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
First received: October 20, 2009
Last updated: March 1, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Drug: MCS-2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Health Ever Bio-Tech Co., Ltd.:

Primary Outcome Measures:
  • Changes in total International Prostate Symptom Scores (I-PSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in I-PSS subscores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in I-PSS quality of life index [ Time Frame: 12 weels ] [ Designated as safety issue: No ]
  • Changes in urinary peak flow rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of withdrawals due to treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 272
Study Start Date: May 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCS-2
Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Drug: MCS-2
30 mg/day (two 15 mg capsules) Qd for 12 weeks
Other Name: MUS
Placebo Comparator: Placebo
Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Drug: Placebo
2 soft-gel placebo capsules Qd for 12 weeks
Other Name: MCS Matching Placebo

Detailed Description:
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.

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01002664

National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.
Principal Investigator: Yeong-Shiau Pu, MD PhD National Taiwan University Hospital
  More Information

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01002664     History of Changes
Other Study ID Numbers: MCS-2-TWN-a 
Study First Received: October 20, 2009
Last Updated: March 1, 2015
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Health Ever Bio-Tech Co., Ltd.:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
International prostate symptom scores

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on May 26, 2016