Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.

Detailed description:
The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: S-equol intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg S-equol 50mg S-equol, \& 150mg S-equol intervention 2: Placebo

Protocol document: