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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ausio Pharmaceuticals, LLC
Sponsor:
Information provided by (Responsible Party):
Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00962390
First received: August 19, 2009
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: S-equol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ausio Pharmaceuticals, LLC:

Primary Outcome Measures:
  • To evaluate the change from baseline in prostate specific antigen concentration after 4 weeks of treatment with 3 dose levels of S-equol and placebo. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and acceptability of S-equol in men with benign prostatic hyperplasia. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: June 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 150mg S-equol Drug: S-equol
10mg S-equol 50mg S-equol, & 150mg S-equol
Other Name: AUS-131
Experimental: 50mg S-equol Drug: S-equol
10mg S-equol 50mg S-equol, & 150mg S-equol
Other Name: AUS-131
Experimental: 10 mg S-equol Drug: S-equol
10mg S-equol 50mg S-equol, & 150mg S-equol
Other Name: AUS-131
Placebo Comparator: Placebo Drug: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962390

Locations
United States, Florida
South Florida Medical Research Recruiting
Aventura, Florida, United States, 33180
Contact: Sayonara Nunez    305-931-8080      
Principal Investigator: Marc Gittelman, MD         
Tampa Bay Medical Research Recruiting
Clearwater, Florida, United States, 33761
Contact: Donald Bergner, MD    727-724-3316    bergner@tbmr.net   
Principal Investigator: Donald Bergner, MD         
United States, Utah
Advanced Clinical Research Suspended
West Jordon, Utah, United States, 84088
United States, Virginia
Clinical Research Associates of Tidewater Recruiting
Norfolk, Virginia, United States, 23507
Contact: Raymond Smith    757-627-7446      
Principal Investigator: Duane Wombolt, MD         
India
Samved Hospital Suspended
Ahmedabad, India
St. John's Medical College Hospital Suspended
Bangalore, India
M S Ramaiah Memorial Hospital Suspended
Bangalore, India
G S Medical College and KEM Hospital Suspended
Delhi, India
V M Medical College and Safdarjung Hospital Suspended
Delhi, India
Indraprastha Apollo Hospital Suspended
Delhi, India
SMS Hospital Suspended
Jaipur, India
A J Hospital and Research Center Suspended
Mangalore, India
Ruby Hall Clinic Suspended
Pune, India
Inamdar Multispecialty Hospital Suspended
Pune, India
Sponsors and Collaborators
Ausio Pharmaceuticals, LLC
Investigators
Principal Investigator: Donald Bergner, MD Tampa Bay Medical Research
  More Information

No publications provided

Responsible Party: Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00962390     History of Changes
Other Study ID Numbers: AUS CT04
Study First Received: August 19, 2009
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Equol
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014