NCT00962390

Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia

Randomized, Double Blind, Multicenter, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy and Safety of 4 Weeks Treatment With AUS 131 (S Equol) on Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Ausio Pharmaceuticals, LLC · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	S-equol	10mg S-equol 50mg S-equol, \& 150mg S-equol
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2009-08-20
• Last updated: 2017-05-19
• Results posted: 2017-05-19

Locations

15 sites across 2 countries: United States, India