NCT00501371

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

Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Health Ever Bio-Tech Co., Ltd. · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	MCS	soft-gel capsule, 15 mg/cap., Qd, 12 weeks
DRUG	Placebo	soft-gel capsule, Qd, 12 weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-07-16
• Last updated: 2011-12-14

Locations

5 sites across 1 country: Taiwan