L-O-M® MCS in the Treatment of Lower Urinary Tract Symptoms

12:30 EDT 31st October 2014 | BioPortfolio

Summary

The hypothesis of the study is to examine whether L-O-M® Multi-Carotenoids (MCS) is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Description

This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.

Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg L-O-M® MCS in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg L-O-M® MCS.

Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the L-O-M® MCS (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of L-O-M® MCS (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Lower Urinary Tract Symptoms

Intervention

L-O-M® MCS 15 mg/day, L-O-M® MCS 30 mg/day, Placebo

Location

David Geffen School of Medicine at UCLA
Los Angeles
California
United States
90095

Status

Not yet recruiting

Source

Health Ever Bio-Tech Co., Ltd.

Results (where available)

View Results

Links

Clinical Trials [924 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of L-O-M® MCS in the Treatment of Lower Urinary Tract Symptoms

The hypothesis of the study is to examine whether L-O-M® Multi-Carotenoids (MCS) is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hype...

Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata

To the investigators knowledge there is no research data published to date regarding the lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are: 1. T...

Efficacy and Safety Study of Dutasteride Combined With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either to...

Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery. The purpose of thi...

A Study of YM178 in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

This study will examine the safety, tolerability, and efficacy of YM178 compared to placebo.

PubMed Articles [13714 Associated PubMed Articles listed on BioPortfolio]

Chronic lower urinary tract symptoms in young men without symptoms of chronic prostatitis: urodynamic analyses in 308 men aged 50 years or younger.

We investigated the etiologies of lower urinary tract symptoms (LUTS) and compared urodynamic characteristics between different diagnostic groups in young men with chronic LUTS.

Pressure-flow nomogram for women with lower urinary tract symptoms.

Results of urodynamic studies performed in female patients are often difficult to interpret. The objective of the study was to develop a nomogram that would help in diagnosing functional bladder outle...

Urodynamic characterization of lower urinary tract symptoms in women less than 40 years of age.

Lower urinary tract symptoms (LUTS) in young women is becoming a more recognized urologic issue that can arise from many causes, each with their own management strategy. The purpose of this study was ...

Does metabolic syndrome increase erectile dysfunction and lower urinary tract symptoms.

To evaluate the impact of metabolic syndrome (MS) on erectile dysfunction (ED) and lower urinary tract symptoms (LUTS).

Efficacy and safety of solifenacin plus tamsulosin oral controlled absorption system in men with lower urinary tract symptoms: a meta-analysis.

We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system (TOCAS) with placebo or TOCAS monotherapy. The aim of the meta-ana...

Medical and Biotech [MESH] Definitions

Lower urinary tract symptom, such as slow urinary stream, associated with PROSTATIC HYPERPLASIA in older men.

A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes, and the genital tract in the male. Common urological problems include urinary obstruction, URINARY INCONTINENCE, infections, and UROGENITAL NEOPLASMS.

Painful URINATION. It is often associated with infections of the lower URINARY TRACT.

A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.

Properties, functions, and processes of the URINARY TRACT as a whole or of any of its parts.

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