Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: S-equol; Placebo
Intervention description: 10mg S-equol 50mg S-equol, & 150mg S-equol; Placebo
Intervention MeSH terms: Equol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No

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

Eligibility criteria:

        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.