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

Completed · Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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

Key facts

Study ID: NCT00962390
Run by: Ausio Pharmaceuticals, LLC
People needed: 116
Starts: 2009-06-01
Expected to finish: 2016-01-01
Last updated by the study team: 2017-05-19

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Medical Affiliated Research Center — Huntsville, Alabama, United States
South Florida Medical Research — Aventura, Florida, United States
Tampa Bay Medical Research — Clearwater, Florida, United States
Advanced Clinical Research — West Jordon, Utah, United States
Clinical Research Associates of Tidewater — Norfolk, Virginia, United States
Samved Hospital — Ahmedabad, India
M S Ramaiah Memorial Hospital — Bangalore, India
St. John's Medical College Hospital — Bangalore, India
G S Medical College and KEM Hospital — Delhi, India
Indraprastha Apollo Hospital — Delhi, India
V M Medical College and Safdarjung Hospital — Delhi, India
SMS Hospital — Jaipur, India
A J Hospital and Research Center — Mangalore, India
Inamdar Multispecialty Hospital — Pune, India
Ruby Hall Clinic — Pune, India

Full record on ClinicalTrials.gov

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