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

NCT00962390 | Completed Phase 2 Results

• 1 other identifier: AUS CT04
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.

  Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.

  4 weeks

Secondary Outcomes (13)

• Change in Prostate Volume From Baseline at Week 4

  4 weeks

• Change in Qmax From Baseline at Week 4

  4 weeks

• Categorical Change in Qmax From Baseline at Week 4

  4 weeks

• Percent Change in Qmax From Baseline at Week 4

  4 weeks

• Change in Void Volume From Baseline at Week 4

  4 weeks

Study Arms (4)

150mg S-equol

EXPERIMENTAL

Drug: S-equol

50mg S-equol

EXPERIMENTAL

Drug: S-equol

10 mg S-equol

EXPERIMENTAL

Drug: S-equol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

S-equol DRUG

10mg S-equol 50mg S-equol, \& 150mg S-equol

Also known as: AUS-131

10 mg S-equol; 150mg S-equol; 50mg S-equol

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ausio Pharmaceuticals, LLC: lead

Study Sites (15)

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Advanced Clinical Research

West Jordon, Utah, 84088, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Samved Hospital

Ahmedabad, India

Location

M S Ramaiah Memorial Hospital

Bangalore, India

Location

St. John's Medical College Hospital

Bangalore, India

Location

G S Medical College and KEM Hospital

Delhi, India

Location

Indraprastha Apollo Hospital

Delhi, India

Location

V M Medical College and Safdarjung Hospital

Delhi, India

Location

SMS Hospital

Jaipur, India

Location

A J Hospital and Research Center

Mangalore, India

Location

Inamdar Multispecialty Hospital

Pune, India

Location

Ruby Hall Clinic

Pune, India

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Equol

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Rick Schwen, PhD, DABT, RAC / Vice President of Regulatory Affairs
• Organization: Ausio Pharmaceuticals, LLC

rick@ausiopharma.com

513-731-0222

Study Officials

• Donald Bergner, MD

  Tampa Bay Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Locations

IN (10); US (5)