CompletedNCT00962390Updated May 19, 2017Results posted

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

A Phase 2 interventional study of S-equol and Placebo in Benign Prostatic Hyperplasia, sponsored by Ausio Pharmaceuticals, LLC. Completed at 15 sites in 2 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Ausio Pharmaceuticals, LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 116
Allocation: Randomized
Ages: 50 Years and older
Sex: Male

Study summary

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 studied

Benign Prostatic Hyperplasia

Browse trials for

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 116 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Ausio Pharmaceuticals, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 116 participants (actual)

Study arms

Experimental
150mg S-equol
Drug: S-equol
Experimental
50mg S-equol
Drug: S-equol
Experimental
10 mg S-equol
Drug: S-equol
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugS-equol
10mg S-equol 50mg S-equol, \& 150mg S-equol
Also known as: AUS-131
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

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.
Time frame: 4 weeks

Secondary outcomes

Change in Prostate Volume From Baseline at Week 4
Prostate size as measured by prostate volume as assessed by transrectal ultrasound.
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
Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit.
Time frame: 4 weeks
Investigators Assessment of Nocturia at Week 4
Investigators were asked to rate participant's change in nocturia since the Baseline Visit.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks

Results

Posted May 19, 2017

Participant flow

Participants were recruited from 4 centers in Australia, 10 centers in India, and 8 centers in the United States from February 2010 to August 2015. The first participant was enrolled in August 2010, and the last participant was enrolled in August 2015.

Participant flow — Overall Study
Milestone	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Started	29	29	29	29
Completed	25	26	25	28
Not completed	4	3	4	1
Withdrew: Adverse event	0	0	3	1
Withdrew: Lost to follow-up	2	2	0	0
Withdrew: Protocol violation	1	0	0	0
Withdrew: Withdrawal by subject	1	1	1	0

Outcome measures

PrimaryChange 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.

Time frame:: 4 weeks
Reported as:: Least squares mean · ng/mL

Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.
ng/mL	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.	-0.1 ± 0.3	-0.1 ± 0.3	-0.3 ± 0.3	-0.4 ± 0.3

Statistical analysis

S-equol 10 mg BID vs Placebo BID · ANCOVA · p = 0.4678 (Statistical testing was 2-sided and the 5% significant level was used.) · Mean difference (final values): 0.3 · 95% CI -0.5 to 1.1S-equol treatment group minus placebo group.
S-equol 50 mg BID vs Placebo BID · ANCOVA · p = 0.4892 (Statistical testing was 2-sided and the 5% significant level was used.) · Mean difference (final values): 0.3 · 95% CI -0.5 to 1.1S-equol treatment group minus placebo group.
S-equol 150 mg BID vs Placebo BID · ANCOVA · p = 0.8185 (Statistical testing was 2-sided and the 5% significant level was used.) · Mean difference (final values): 0.1 · 95% CI -0.8 to 1.0S-equol treatment group minus placebo group.

SecondaryChange in Prostate Volume From Baseline at Week 4

Prostate size as measured by prostate volume as assessed by transrectal ultrasound.

Time frame:: 4 weeks
Reported as:: Mean · mL

Change in Prostate Volume From Baseline at Week 4
mL	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	40.03 ± 12.10	45.53 ± 15.36	39.16 ± 10.67	39.73 ± 13.98
Change from Baseline	-3.03 ± 5.28	-0.25 ± 8.29	-1.72 ± 7.31	-1.74 ± 5.10

SecondaryChange in Qmax From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · mL/sec

Change in Qmax From Baseline at Week 4
mL/sec	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	11.00 ± 5.87	10.10 ± 5.41	14.40 ± 5.70	13.40 ± 6.57
Change from Baseline	0.96 ± 4.74	-0.09 ± 6.13	2.49 ± 6.25	2.25 ± 6.63

SecondaryCategorical Change in Qmax From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Count of participants · Participants

Categorical Change in Qmax From Baseline at Week 4
Participants	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values, <=2 mL/sec	17	19	13	17
Week 4 Values, >2 mL/sec	8	7	10	11

SecondaryPercent Change in Qmax From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Count of participants · Participants

Percent Change in Qmax From Baseline at Week 4
Participants	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values, <=30%	18	22	13	19
Week 4 Values, >30%	7	4	9	9

SecondaryChange in Void Volume From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · mL

Change in Void Volume From Baseline at Week 4
mL	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	235.04 ± 124.23	191.50 ± 88.79	312.09 ± 187.12	266.32 ± 119.92
Change from Baseline	4.04 ± 128.97	-58.00 ± 116.23	72.18 ± 154.08	7.46 ± 134.59

SecondaryChange in Post-Void Residual Volume From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · mL

Change in Post-Void Residual Volume From Baseline at Week 4
mL	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	77.90 ± 96.73	83.54 ± 96.98	52.46 ± 68.14	85.90 ± 81.25
Change from Baseline	2.51 ± 93.12	17.08 ± 93.73	-18.22 ± 69.97	-6.28 ± 73.29

SecondaryChange in in Dihydrotestosterone Concentration From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · pg/mL

Change in in Dihydrotestosterone Concentration From Baseline at Week 4
pg/mL	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	584.7 ± 567.0	532.4 ± 483.1	616.6 ± 661.9	502.4 ± 434.5
Change from Baseline	64.2 ± 313.1	-6.2 ± 139.9	68.1 ± 488.9	-14.5 ± 72.9

SecondaryChange in Luteinizing Hormone Concentration From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · IU/L

Change in Luteinizing Hormone Concentration From Baseline at Week 4
IU/L	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	4.4 ± 2.6	6.0 ± 3.4	6.1 ± 4.1	5.9 ± 2.9
Change from Baseline	-0.6 ± 2.2	1.1 ± 2.5	-0.3 ± 2.4	0.0 ± 2.0

SecondaryChange in Total Testosterone Concentration From Baseline at Week 4

Time frame:: 4 weeks
Reported as:: Mean · nmol/L

Change in Total Testosterone Concentration From Baseline at Week 4
nmol/L	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	449.9 ± 283.7	310.3 ± 204.2	314.0 ± 177.2	351.3 ± 176.8
Change from Baseline	-8.1 ± 116.4	-2.6 ± 173.8	3.7 ± 93.9	-34.4 ± 128.4

SecondaryParticipants 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.

Time frame:: 4 weeks
Reported as:: Median · number of times to urinate at night

Participants Assessment of Nocturia at Week 4
number of times to urinate at night	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Participants Assessment of Nocturia at Week 4	3.0 (1 to 6)	3.0 (1 to 5)	3.0 (2 to 7)	3.0 (1 to 4)

SecondaryInvestigators Assessment of Nocturia at Week 4

Investigators were asked to rate participant's change in nocturia since the Baseline Visit.

Time frame:: 4 weeks
Reported as:: Median · number of times urinated at night

Investigators Assessment of Nocturia at Week 4
number of times urinated at night	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Investigators Assessment of Nocturia at Week 4	3.0 (1 to 6)	3.0 (1 to 5)	3.0 (1 to 4)	3.0 (1 to 4)

SecondaryChange 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.

Time frame:: 4 weeks
Reported as:: Mean · units on a scale

Change in I-PSS Total Score From Baseline at Week 4
units on a scale	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Week 4 Values	15.56 ± 5.35	17.46 ± 5.79	17.54 ± 6.96	15.07 ± 7.62
Change from Baseline	-5.81 ± 7.56	-6.18 ± 5.55	-4.15 ± 6.42	-5.96 ± 5.83

SecondaryChange 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.

Time frame:: 4 weeks
Reported as:: Mean · units on a scale

Change in DAN Prostate Symptom Scale From Baseline at Week 4
units on a scale	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Total Score, Week 4 Values	17.7 ± 10.9	22.1 ± 14.9	22.7 ± 14.6	20.3 ± 20.8
Total Score, Change from Baseline	-8.2 ± 12.9	-11.5 ± 15.4	-4.7 ± 12.0	-10.0 ± 15.2
Sexual Function Score, Week 4 Values	2.2 ± 3.1	4.2 ± 5.4	5.6 ± 3.8	4.7 ± 5.9
Sexual Function Score, Change from Baseline	-0.3 ± 1.6	0.2 ± 2.9	-1.2 ± 4.7	0.3 ± 2.5

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
S-equol 10 mg BID	0/28 (0%)	1/28 (3.6%)	6/28 (21.4%)
S-equol 50 mg BID	0/29 (0%)	0/29 (0%)	5/29 (17.2%)
S-equol 150 mg BID	0/29 (0%)	1/29 (3.4%)	8/29 (27.6%)
Placebo BID	0/29 (0%)	0/29 (0%)	5/29 (17.2%)

Most frequent serious events

Most frequent serious events
Event	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
Blood pressure increasedInvestigations	1/28	0/29	0/29	0/29
Electrocardiogram abnormalInvestigations	1/28	0/29	0/29	0/29
Heart rate increasedInvestigations	1/28	0/29	0/29	0/29
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/28	0/29	1/29	0/29

Most frequent other events

Showing 10 of 33

Most frequent other events
Event	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID
ConstipationGastrointestinal disorders	2/28	0/29	0/29	1/29
HeadacheNervous system disorders	2/28	1/29	0/29	0/29
NauseaGastrointestinal disorders	1/28	0/29	0/29	1/29
Micturition disorderRenal and urinary disorders	1/28	0/29	0/29	0/29
PollakiuriaRenal and urinary disorders	1/28	0/29	0/29	0/29
Urine flow decreasedRenal and urinary disorders	1/28	0/29	0/29	0/29
Vision BlurredEye disorders	0/28	0/29	1/29	0/29
DiarrhoeaGastrointestinal disorders	0/28	1/29	0/29	0/29
Faeces hardGastrointestinal disorders	0/28	1/29	0/29	0/29
Gastro-oesophageal reflux diseaseGastrointestinal disorders	0/28	0/29	1/29	0/29

Baseline characteristics

Participants who took at least one (1) dose of investigational product were included in the baseline analysis population.

Age, Continuous
Age, Continuous(years)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Mean	63.1 ± 9.1	64.6 ± 6.5	63.1 ± 8.8	62.7 ± 7.7	63.4 ± 8.0

Sex: Female, Male
Sex: Female, Male(Participants)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Female	0	0	0	0	0
Male	28	29	29	29	115

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Hispanic or Latino	2	1	2	3	8
Not Hispanic or Latino	26	28	27	26	107
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	10	11	11	13	45
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	3	3	3	0	9
White	14	15	15	16	60
More than one race	0	0	0	0	0
Unknown or Not Reported	1	0	0	0	1

Prostate specific antigen (PSA) concentration
Prostate specific antigen (PSA) concentration(ng/mL)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Mean	3.509 ± 2.241	3.308 ± 1.796	3.210 ± 1.075	3.514 ± 1.860	3.386 ± 1.775

Prostate Volume
Prostate Volume(mL)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Mean	43.46 ± 13.47	44.79 ± 14.27	40.83 ± 11.40	41.41 ± 11.39	42.61 ± 12.62

Post Void Residual Urine Volume
Post Void Residual Urine Volume(mL)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Mean	74.59 ± 60.45	62.00 ± 55.93	61.38 ± 60.37	89.07 ± 56.01	71.91 ± 58.55

Qmax Result
Qmax Result(mL/second)	S-equol 10 mg BID	S-equol 50 mg BID	S-equol 150 mg BID	Placebo BID	Total
Mean	10.22 ± 3.13	10.27 ± 3.29	11.17 ± 3.30	10.98 ± 3.59	10.66 ± 3.32

6 further baseline measures are reported on the registry.

Study locations

15 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00962390
Lead sponsor: Ausio Pharmaceuticals, LLC
Responsible party: Sponsor
First posted: Aug 20, 2009
Start date: Jun 2009
Primary completion: Jan 2016
Completion: Jan 2016
Results posted: May 19, 2017
Last update: May 19, 2017

Study contacts

Donald Bergner, MD

principal investigator · Tampa Bay Medical Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Hyperplasia→

Other studies from this sponsor

Ausio Pharmaceuticals, LLC

Start the discussion