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

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 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 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.