Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
The purpose of this study is to assess the safety and effectiveness of S-equol in men with
 benign prostatic hyperplasia.
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.
Inclusion Criteria:

 -  Is male > 50 years of age at Screening.

 -  Has a normal digital rectal exam with the exception of prostate enlargement.

 -  Has suffered from symptoms of BPH for at least the 6 months before Screening.

 -  Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound.

 -  Has a serum PSA concentration > 1.5 ng/mL and ≤ 10 ng/mL at Screening.

 -  Has an IPSS > 13 at Screening and Baseline.

 -  Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume ≥ 125 cc at Screening (and
 Baseline, if applicable).

 Exclusion Criteria:

 -  Has a known history of allergic reaction or clinically significant intolerance to
 ingredients of the study drug.

 -  Neurogenic bladder dysfunction.

 -  Has bladder neck contracture or urethral stricture.

 -  Has acute or chronic prostatitis or urinary tract infection.

 -  Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on
 digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10
 ng/mL; patients with a PSA concentration > 4 ng/mL and ≤ 10 ng/mL must have prostate
 cancer ruled out to the satisfaction of the investigator.

 -  Has a residual void volume > 250 mL.

 -  Has any clinically significant unstable condition that, in the opinion of the
 investigator, could compromise the patient's welfare, ability to communicate with the
 study staff, or otherwise contraindicate study participation.

 -  Shows presence of any manifest premalignant or malignant disease except treated skin
 cancers (except melanoma).

 -  Has a history of smoking more than 5 cigarettes daily within the year before
 Screening.

 -  Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90
 mmHg or < 60 mmHg at Screening.

 -  Has bladder stones as detected by ultrasound.

 -  Has hematuria of unknown etiology.

 -  Had previous prostate surgery or other invasive treatment for BPH.

 -  Had prior radiation to the pelvis.

 -  Has Parkinson's disease or multiple sclerosis.

 -  Had stroke or myocardial infarction within 5 months before Baseline.

 -  Has abnormal screening electrocardiogram (ECG) or unstable angina or severe congestive
 heart failure.

 -  Has active liver disease renal insufficiency with creatinine > 1.7 mg/dL, or
 clinically significant abnormal hemoglobin, white blood cell count, or platelet count.

 -  Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2
 minutes in a standing position.

 -  Received alpha blocker therapy within 28 days before Baseline.

 -  Received androgens, anti androgens, 5 alpha reductase inhibitors, or luteinizing
 hormone releasing hormone (LHRH) analogs within 3 months before Baseline.

 -  Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1
 month before Baseline.

 -  Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week
 before Baseline.

 -  Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise
 are not on stable doses of phosphodiesterase 5 inhibitors during the 4 weeks before
 Screening.

 -  Has known or suspected history of alcoholism or drug abuse or misuse within the last 5
 years.

 -  Is considered by the investigator, for any reason (including, but not limited to, the
 risks described as precautions, warnings, and contraindications in the current version
 of the Clinical Investigator's Brochure for AUS 131 [S equol]), to be an unsuitable
 candidate to receive the study drug.

 -  Has tested positive on the urine drug screen.