Track topics on Twitter Track topics that are important to you
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.
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 MCS-2 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 MCS-2.
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 MCS-2 (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 MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Lower Urinary Tract Symptoms
MCS-2 15 mg/day, MCS-2 30 mg/day, Placebo
David Geffen School of Medicine at UCLA
Health Ever Bio-Tech Co., Ltd.
Published on BioPortfolio: 2015-03-27T05:38:42-0400
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...
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...
Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate to sever...
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...
This study will examine the safety, tolerability, and efficacy of YM178 compared to placebo.
Lower urinary tract symptoms (LUTS) can frequently be seen in pregnant women. Pregnancy and delivery have been considered as risk factors in the occurrence of pelvic floor dysfunction and determinants...
To date, there is no overall agreement as to risk of ambient temperature for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Thus, we focused on ambient temperature as a...
Efficacy and Safety of Desmopressin "Add-On" Therapy in Men with Persistent Nocturia Under Alpha Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo-Controlled Study.
We investigated the efficacy and safety of desmopressin add-on therapy in men with persistent nocturia on alpha-blocker for lower urinary tract symptoms (LUTS) with placebo-controlled study.
Lower urinary tract dysfunctions (LUTD) are very common in neurological diseases. TENS is a therapeutic alternative in the treatment of urinary and pelvic perineal symptoms, whose effectiveness has be...
To evaluate the prevalence and associated risk factors of lower urinary tract symptoms (LUTS) in people with stroke. This was the first study that systematically surveyed the risk factors for LUTS in ...
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.