Benign Prostatic HyperplasiaPhase 2NCT00962390

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

A Phase 2 study testing S-equol in people with Benign Prostatic Hyperplasia, run by Ausio Pharmaceuticals, LLC at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: S-equol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 15 sitesin 2 countries
Study dates: Jun 2009to Jan 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 27Show fewer

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.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

India10 sites

Samved Hospital
Ahmedabad
M S Ramaiah Memorial Hospital
Bangalore
St. John's Medical College Hospital
Bangalore
G S Medical College and KEM Hospital
Delhi
Indraprastha Apollo Hospital
Delhi
V M Medical College and Safdarjung Hospital
Delhi
SMS Hospital
Jaipur
A J Hospital and Research Center
Mangalore
Inamdar Multispecialty Hospital
Pune
Ruby Hall Clinic
Pune

Other trials in India

United States5 sites

South Florida Medical Research
Aventura, Florida, 33180
Tampa Bay Medical Research
Clearwater, Florida, 33761
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Advanced Clinical Research
West Jordon, Utah, 84088

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Benign Prostatic Hyperplasia
Being tested: S-equol, Placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

S-equolDrug
Also called AUS-131
10mg S-equol 50mg S-equol, \& 150mg S-equol
PlaceboDrug
Placebo

Study groups in NCT00962390
Study group	Role	What they receive
150mg S-equol	Experimental	Not described Receives: Drug: S-equol
50mg S-equol	Experimental	Not described Receives: Drug: S-equol
10 mg S-equol	Experimental	Not described Receives: Drug: S-equol
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks

Secondary outcomes (13)

Change in Prostate Volume From Baseline at Week 4
Prostate size as measured by prostate volume as assessed by transrectal ultrasound.
Measured: 4 weeks
Change in Qmax From Baseline at Week 4
Measured: 4 weeks
Categorical Change in Qmax From Baseline at Week 4
Measured: 4 weeks
Percent Change in Qmax From Baseline at Week 4
Measured: 4 weeks
Change in Void Volume From Baseline at Week 4
Measured: 4 weeks
Change in Post-Void Residual Volume From Baseline at Week 4
Measured: 4 weeks
Change in in Dihydrotestosterone Concentration From Baseline at Week 4
Measured: 4 weeks
Change in Luteinizing Hormone Concentration From Baseline at Week 4
Measured: 4 weeks
Change in Total Testosterone Concentration From Baseline at Week 4
Measured: 4 weeks
Participants Assessment of Nocturia at Week 4
Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit.
Measured: 4 weeks
Investigators Assessment of Nocturia at Week 4
Investigators were asked to rate participant's change in nocturia since the Baseline Visit.
Measured: 4 weeks
Change in I-PSS Total Score From Baseline at Week 4
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH.
Measured: 4 weeks
Change in DAN Prostate Symptom Scale From Baseline at Week 4
The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jan 2016

First posted20 Aug 2009 (estimated)
Study startJun 2009
Primary completionJan 2016
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00962390
Sponsor's protocol ID: AUS CT04
Status last verified: Apr 2017
First submitted: 19 Aug 2009
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00962390
Acronym / sponsor ID: AUS CT04
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Ausio Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 20 Aug 2009 (estimated)
Results: Posted 19 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (27 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S-equolAlso: AUS-13110mg S-equol 50mg S-equol, \& 150mg S-equol	Drug	10 mg S-equol, 150mg S-equol, 50mg S-equol
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.
Time frame: 4 weeks
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.

13 secondary outcomes

Change in Prostate Volume From Baseline at Week 4
Time frame: 4 weeks
Change in Qmax From Baseline at Week 4
Time frame: 4 weeks
Categorical Change in Qmax From Baseline at Week 4
Time frame: 4 weeks
Percent Change in Qmax From Baseline at Week 4
Time frame: 4 weeks
Change in Void Volume From Baseline at Week 4
Time frame: 4 weeks
Change in Post-Void Residual Volume From Baseline at Week 4
Time frame: 4 weeks
Change in in Dihydrotestosterone Concentration From Baseline at Week 4
Time frame: 4 weeks
Change in Luteinizing Hormone Concentration From Baseline at Week 4
Time frame: 4 weeks
Change in Total Testosterone Concentration From Baseline at Week 4
Time frame: 4 weeks
Participants Assessment of Nocturia at Week 4
Time frame: 4 weeks
Investigators Assessment of Nocturia at Week 4
Time frame: 4 weeks
Change in I-PSS Total Score From Baseline at Week 4
Time frame: 4 weeks
Change in DAN Prostate Symptom Scale From Baseline at Week 4
Time frame: 4 weeks

Results and safety

Results posted to the registry on 19 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
S-equol 10 mg BID	29	25
S-equol 50 mg BID	29	26
S-equol 150 mg BID	29	25
Placebo BID	29	28

Primary outcome: Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.

Time frame: 4 weeks. Least squares mean (Standard Error). Unit: ng/mL

Measure	S-equol 10 mg BID n = 25	S-equol 50 mg BID n = 26	S-equol 150 mg BID n = 24	Placebo BID n = 29
Value	-0.1 (0.3)	-0.1 (0.3)	-0.3 (0.3)	-0.4 (0.3)

S-equol 10 mg BID vs Placebo BID: Mean Difference (Final Values): 0.3 (95% CI -0.5 to 1.1), p = 0.4678, ANCOVA
S-equol 50 mg BID vs Placebo BID: Mean Difference (Final Values): 0.3 (95% CI -0.5 to 1.1), p = 0.4892, ANCOVA
S-equol 150 mg BID vs Placebo BID: Mean Difference (Final Values): 0.1 (95% CI -0.8 to 1.0), p = 0.8185, ANCOVA

Population analysed: All Participants who received at least 1 dose of study drug and who had a post-dose PSA assessment at Week 4.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the time of signing of the ICF through the Follow-up Visit (Visit 6) or Early Termination Visit (whichever occurred first), up to Day 56±2 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
S-equol 10 mg BID	1 of 28 (3.6%)	6 of 28 (21.4%)	0 of 28
S-equol 50 mg BID	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29
S-equol 150 mg BID	1 of 29 (3.4%)	8 of 29 (27.6%)	0 of 29
Placebo BID	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Benign Prostatic Hyperplasia

Recruiting
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Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald Bergner, MD principal investigator

Tampa Bay Medical Research

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-equol in people with Benign Prostatic Hyperplasia, run by Ausio Pharmaceuticals, LLC at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.