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CTRI Number  CTRI/2012/05/002683 [Registered on: 22/05/2012] Trial Registered Prospectively
Last Modified On: 14/02/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the safety and efficacy of S-equol in the treatment of Benign Prostate Hyperplasia. 
Scientific Title of Study   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 
Trial Acronym  AUS-CT04 
Secondary IDs if Any  
Secondary ID  Identifier 
AUS-CT04 Amendment #4, Version 2.5, dated 13 Apr 2012  Protocol Number 
F.No.CT/124/11-DCG (I)  DCGI 
NCT00962390  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Sushma Srikanth 
Designation  Clinical Operations Manager 
Affiliation  Novotech Clinical Research private limited 
Address  Novotech® Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road Bangalore,India Sushma.Srikanth@novotech-cro.com | direct: +91 80 4164 8994 | mobile: +91 988 0665889

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  Sushma.Srikanth@novotech-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sushma Srikanth 
Designation  Clinical Operations Manager 
Affiliation  Novotech Clinical Research private limited 
Address  Novotech Clinical Research private limited Unit #1103, 11th Floor, Prestige Meridian-1, #29, M.G. Road, 560001 Bangalore, India Phone: +91 80 4164 8996 Fax: +91 80 6688 5634

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  Sushma.Srikanth@novotech-cro.com  
 
Details of Contact Person
Public Query  
Name  Ms Sushma Srikanth 
Designation  Clinical Operations Manager 
Affiliation  Novotech Clinical Research private limited 
Address  Novotech Clinical Research private limited Unit #1103, 11th Floor, Prestige Meridian-1, #29, M.G. Road, 560001 Bangalore, India Phone: +91 80 4164 8996 Fax: +91 80 6688 5634

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  Sushma.Srikanth@novotech-cro.com  
 
Source of Monetary or Material Support  
Novotech® Unit# 1103, Level 11 Prestige Meridian-1 29,M.G.Road Bangalore,India +91 80 4164 8994  
 
Primary Sponsor  
Name  Ausio Pharmaceuticals LLC 
Address  1776 Mentor Ave, Suite 340 Cincinnati, OH 45212 USA 513-731-1600 513-731-0444 (fax) 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Australia
United States of America  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shams Abdul Kadar Iqbal  Inamdar Multispeciality Hospital,  Inamdar Multispeciality Hospital, Hospital Building S. No, 15, Fatima Nagar, Pune - 411 040. India.
Pune
MAHARASHTRA 		 02030502222

drshamsi@hotmail.com 
Dr Ajit Saxena  Indraprastha Apollo Hospitals  Indraprastha Apollo Hospitals, Sarita Vihar, Delhi-Mathura Road New Delhi -110076, India
South
DELHI 		 01126925858

ajitsaxena@hotmail.com 
DrHKNagaraju  M S Ramaiah Memorial Hospital  M S Ramaiah Memorial Hospital New BEL Road, MSRIT Post, Bangalore - 560054, India.
Bangalore
KARNATAKA 		 08025299247

nagarajharohally@hotmail.com 
Dr Sujata Patwardhan  Seth G S Medical College and KEM Hospital  Department of Urology, 8th Floor, New Building, Seth G S Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400 012. India.
Mumbai
MAHARASHTRA 		 02224107495

sujata.patwardhan@rediffmail.com 
Dr Sher Singh Yadav  SMS Hospital  Department of Urology, SMS Hospital, JLN Marg, Jaipur – 302004, Rajasthan.
Jaipur
RAJASTHAN 		 01416594299

dryadavsms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethical Review Board,M.S. Ramaiah Medical College & Hospitals, MSR Nagar New BEL Road, MSRIT Post, Bangalore -560054  Approved 
Ethics committee for research on Human Subjects,G. S. Medical Colllege and KEM Hospital, Parel, Mumbai   Approved 
Ethics committee of SMS Medical college and attached Hospitals,SMS Medical Hospital, JLN Marg, Jaipur - 302004  Approved 
Ethics Committee on Clinical Trials,Indraprastha Apollo Hospitals, Sarita Vihar, Delhi   Approved 
Ethics Committee-Inamdar Multispeciality Hospital,Inamdar Multispecialty Hospital, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Benign Prostatic Hyperplasia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AUS-131 (S-equol) capsules 10 mg BID (20 mg total daily dose)for oral administration for 4 Weeks  S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-β agonist that Ausio Pharmaceuticals LLC (Ausio) is developing for the treatment of BPH in men. 
Intervention  AUS-131 (S-equol) capsules 150 mg BID (300 mg total daily dose)for oral administration for 4 Weeks  S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-β agonist that Ausio Pharmaceuticals LLC (Ausio) is developing for the treatment of BPH in men. 
Intervention  AUS-131 (S-equol) capsules 50 mg BID (100 mg total daily dose)for oral administration for 4 Week  S-equol (AUS-131), the S-enantiomer of equol, is a potent, selective estrogen receptor (ER)-β agonist that Ausio Pharmaceuticals LLC (Ausio) is developing for the treatment of BPH in men. 
Comparator Agent  AUS-CT-04 is a Placebo-Controlled,Non-comparative, Proof-of-Concept Trial  Patients in all treatment groups, including placebo, may leave the study for any reason, including for reasons of adverse events. Such patients will be referred to their physician, and provided medical advice from the Principal Investigator, regarding what medical treatment (rescue strategy) would be appropriate for their condition. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Inclusion Criteria
A patient will be eligible for study entry if all of the following inclusion criteria are
met:
1. Is male > 50 and ≤70 years of age at Screening.
2. Has a normal digital rectal exam with the exception of prostate enlargement.
3. Has suffered from symptoms of BPH for at least the 6 months before Screening (e.g., micturition disturbances such as daytime frequency, nocturia, urgency, difficulty initiating micturition, impaired quality of the urinary stream, feeling of incomplete voiding, or interruption of the urinary stream).
4. Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound.
5. Has a serum PSA concentration > 1.5 ng/mL and ≤ 10 ng/mL at Screening.
6. Has an IPSS ≥ 13 at Screening and Baseline.
7. Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable).
8. Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.
9. Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the conduct of any study procedure.
10. Is willing and able to comply with all study requirements and instructions of the site study staff. 
 
ExclusionCriteria 
Details  Exclusion Criteria
A patient will not be eligible for study entry if any of the following exclusion criteria are met:
1. Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
2. Neurogenic bladder dysfunction.
3. Has bladder neck contracture or urethral stricture.
4. Has acute or chronic prostatitis or urinary tract infection.
5. 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.
6. Has a residual void volume > 250 mL.
7. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, renal, endocrine, or gastric disease or any other 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.
8. Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
9. Has a history of smoking more than 5 cigarettes daily within the year before
Screening.
10. Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic
BP > 90 mmHg or < 60 mmHg at Screening.
11. Has bladder stones as detected by ultrasound.
12. Has hematuria of unknown etiology.
13. Had previous prostate surgery or other invasive treatment for BPH.
14. Had prior radiation to the pelvis.
15. Has Parkinson’s disease or multiple sclerosis.
16. Had stroke or myocardial infarction within 5 months before Baseline.
17. Has clinically significant abnormal screening electrocardiogram (ECG) or unstable
angina or severe congestive heart failure.
18. Has active liver disease with aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) > 2 times ULN, unexplained alkaline phosphatase > 3 times ULN, total bilirubin > ULN, renal insufficiency with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
19. Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2 minutes in a standing position.
20. Received alpha blocker therapy within 28 days before Baseline.
21. Received androgens, anti-androgens, 5-alpha reductase inhibitors, or luteinizing hormone-releasing hormone (LHRH) analogs within 3 months before Baseline.
22. Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
23. Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
24. 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.
25. Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
26. 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.
27. Has tested positive on the urine drug screen. Patients who test positive at Screening and can produce documentation from their physician for the medication that
caused the positive test may be considered for study enrollment at the discretion of the investigator.
28. Has significant difficulties swallowing capsules or is unable to tolerate oral
medication.
29. Has participated in another clinical trial or received any investigational drug or device or investigational therapy within 30 days before Screening. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoint is the change from Baseline in PSA concentration at the Week 4
Visit (V5). 		 Day 28 ±2 days 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints are the following: • Change from Baseline in prostate size (assessed by transrectal ultrasonography)
• Change from Baseline in Qmax
• Percent of patients with change from Baseline in Qmax 2 cc/sec
• Percent of patients with change from Baseline in Qmax 30% • Change from Baseline in PSA concentration
• Change from Baseline in PSA density 		 Change from Baseline in prostate size
Change from Baseline in Qmax 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   22/05/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/08/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
The preclinical and clinical data available indicate that AUS-131 is well tolerated and presents an
acceptable risk-to-benefit ratio to the patient.
Two Phase 1 clinical studies have been completed. An acceptable safety profile was reported in both these studies. The TEAE for study drug were similar to placebo and only 2 mild TEAE
(abdominal cramps and nausea) were considered related to study drug for both studies. Since the safety data is blinded it is not known if these TEAE are in the placebo or drug groups. The potential benefits of a potent ER-β agonist to effectively treat the symptoms of benign prostatic hyperplasia while providing minimal risk to the patient would be unprecedented.
The PK data from the single dose Phase 1 study AUS-CT01, indicate that, based on the T1/2 for
AUS-131, a BID dosing regimen is appropriate to ensure adequate systemic exposure at steady state. The PK data from the multidose Phase 1 study, AUS-CT02, confirmed a BID dosing regimen is appropriate. The 10, 50, and 150-mg BID doses in the current study are comparable to
the dosing regimen in the 14-day AUS-CT02 study with dosing cohorts of 10, 20, 40, 80, or 160 mg BID. The older individuals (45-65 years) had different PK profiles compared to the younger group (18-44 years) in the single-dose Phase 1 study, AUS-CT01. However, the safety profile was similar between groups. Dose-normalized AUC0-12 and Cmax were not significantly different between the younger and older age groups, for single and steady state doses in the multidose Phase 1 study, AUS-CT02. The safety profile was similar between the older individuals compared to the younger individuals for both studies which suggest the safety profile
for the Phase 2 studies will be similar to those reported in the Phase 1 studies.
 
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