MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia

Last updated: December 13, 2011
Sponsor: Health Ever Bio-Tech Co., Ltd.
Overall Status: Terminated

Phase

3

Condition

Bladder Disorders

Interstitial Cystitis

Enuresis

Treatment

N/A

Clinical Study ID

NCT00501371
MCS for BPH-LUTS
  • Ages > 40
  • Male

Study Summary

Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.

Subproject MCS-2: alpha-blocker naïve subjects

Subproject MCS-3: subjects responding poorly to alpha-blocker

Eligibility Criteria

Inclusion

Inclusion criteria for subproject MCS-2

  • Age ≧ 40 years old.

  • Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.

  • PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.

  • No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

  • AST/ALT≦3X UNL.

  • creatinine≦3X UNL.

  • Subjects who sign the informed consent form.

Exclusion criteria

  • Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

  • Have been treated with pelvis irradiation or pelvic surgery.

  • Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.

  • Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.

  • Active infection or inflammation.

  • Considered ineligible by the investigators.

Inclusion criteria for subproject MCS-3

  • Age≧40 years old.

  • The alpha-blocker dosage used should be as high as subjects can tolerate.

  • No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

  • PSA≦10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory > 12 weeks before screening, if PSA is≧4 ng/ml to rule out prostate cancer.

  • AST/ALT≦3X UNL.

  • Creatinine≦3X UNL.

  • Subjects who sign the informed consent form.

Exclusion criteria

  • Subjects' LUTS are not BPH-related but associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

  • Subjects who have been treated with pelvis irradiation or pelvic surgery.

  • PSA > 10.0 ng/ml, abnormal DRE of the prostate or any suspicion of prostate malignancy. However, those who have a negative prostate biopsy are allowed.

  • Active infection or inflammation.

  • Considered ineligible by the investigators.

Study Design

Total Participants: 85
Study Start date:
July 01, 2007
Estimated Completion Date:
October 31, 2009

Study Description

For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.

Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.

For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.

Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study.

All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.

Connect with a study center

  • Chang Gung Memorial Hospital

    Chiayi, 613
    Taiwan

    Site Not Available

  • Chung-Ho Memorial Hospital,Kaohsiung Medical University

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.