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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962390
• Other study ID #: AUS CT04
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2009
• Last updated: January 8, 2016
• Start date: June 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Ausio Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• S-equol
10mg S-equol 50mg S-equol, & 150mg S-equol
• Placebo
Placebo

Locations

Country	Name	City	State
India	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
United States	South Florida Medical Research	Aventura	Florida
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Advanced Clinical Research	West Jordon	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Ausio Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 weeks	No
Secondary	To assess the safety and acceptability of S-equol in men with benign prostatic hyperplasia.		4 weeks	No