Benign Prostatic Hyperplasia Clinical Trial
Official title:
An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects
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
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