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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00962390
First received: August 19, 2009
Last updated: April 12, 2017
Last verified: April 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Interventions: Drug: S-equol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
S-equol 10 mg BID

Experimental: S-equol

Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.

S-equol 50 mg BID

Experimental: S-equol

Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.

S-equol 150 mg BID

Experimental: S-equol

Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.

Placebo BID

Placebo Comparator: Placebo

Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.


Participant Flow:   Overall Study
    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 
Adverse Event                0                0                3                1 
Lost to Follow-up                2                2                0                0 
Protocol Violation                1                0                0                0 
Withdrawal by Subject                1                1                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who took at least one (1) dose of investigational product were included in the baseline analysis population.

Reporting Groups
  Description
S-equol 10 mg BID

Experimental: S-equol

Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.

S-equol 50 mg BID

Experimental: S-equol

Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.

S-equol 150 mg BID

Experimental: S-equol

Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.

Placebo BID

Placebo Comparator: Placebo

Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.

Total Total of all reporting groups

Baseline Measures
   S-equol 10 mg BID   S-equol 50 mg BID   S-equol 150 mg BID   Placebo BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   29   29   29   115 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   29   29   29   115 
   63.1  (9.1)   64.6  (6.5)   63.1  (8.8)   62.7  (7.7)   63.4  (8.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 28   29   29   29   115 
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      28 100.0%      29 100.0%      29 100.0%      29 100.0%      115 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 28   29   29   29   115 
Hispanic or Latino      2   7.1%      1   3.4%      2   6.9%      3  10.3%      8   7.0% 
Not Hispanic or Latino      26  92.9%      28  96.6%      27  93.1%      26  89.7%      107  93.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 28   29   29   29   115 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      10  35.7%      11  37.9%      11  37.9%      13  44.8%      45  39.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  10.7%      3  10.3%      3  10.3%      0   0.0%      9   7.8% 
White      14  50.0%      15  51.7%      15  51.7%      16  55.2%      60  52.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   3.6%      0   0.0%      0   0.0%      0   0.0%      1   0.9% 
Prostate specific antigen (PSA) concentration [1] 
[Units: ng/mL]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   29   113 
   3.509  (2.241)   3.308  (1.796)   3.210  (1.075)   3.514  (1.860)   3.386  (1.775) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Prostate Volume [1] 
[Units: mL]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   29   113 
   43.46  (13.47)   44.79  (14.27)   40.83  (11.40)   41.41  (11.39)   42.61  (12.62) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Post Void Residual Urine Volume [1] 
[Units: mL]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   29   113 
   74.59  (60.45)   62.00  (55.93)   61.38  (60.37)   89.07  (56.01)   71.91  (58.55) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Qmax Result [1] 
[Units: mL/second]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   29   113 
   10.22  (3.13)   10.27  (3.29)   11.17  (3.30)   10.98  (3.59)   10.66  (3.32) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Void Volume [1] 
[Units: mL]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   29   113 
   229.21  (128.59)   245.75  (111.49)   243.54  (115.54)   261.48  (86.07)   245.14  (110.39) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Dihydrotestosterone [1] 
[Units: pg/mL]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   26   27   109 
   496.2  (425.2)   533.6  (388.5)   534.7  (467.4)   446.1  (185.5)   502.6  (378.3) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Luteinizing Hormone [1] 
[Units: IU/L]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   26   28   110 
   5.4  (4.2)   5.1  (2.5)   6.5  (4.1)   5.9  (2.8)   5.7  (3.5) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Testosterone, Total [1] 
[Units: nmol/L]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   26   28   110 
   442.6  (311.7)   319.9  (248.0)   340.6  (180.9)   372.7  (202.0)   369.5  (243.2) 
[1] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Total International Prostate Symptom Score (I-PSS) [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   28   28   112 
   21.11  (5.24)   23.64  (4.57)   21.50  (4.59)   21.32  (5.21)   21.89  (4.96) 
[1] The I-PSS is based on the answers to 7 questions concerning urinary symptoms and one question concerning the quality of life. Each question concerning urinary symptoms allows the subject to choose 1 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 (asymptomatic) to 35 (very symptomatic).
[2] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.
Total Danish Prostatic Symptom Score (DAN-PSS-1) [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed 
[Units: Participants]
 28   28   29   29   114 
   26.1  (10.9)   33.5  (15.3)   27.2  (15.5)   31.1  (19.1)   29.5  (15.6) 
[1] The DAN-PSS-1 is a self-administered quality-of-life questionnaire comprising 12 questions related to lower urinary tract symptoms (bladder storage and voiding function), and 3 questions related to sexual function (symptom score). All answers for symptom and bothersomeness were classified in a 4-ranked scale from 0 (absence of symptoms or no impact on daily life) to 3 (the maximum severity of symptoms or impact on daily life). A weighted score was then calculated to give a total score that ranged from 0 to 108, where higher scores represented worsening symptoms and bothersomeness.
[2] Participants who had taken at least one (1) dose of investigational product and had a baseline value of interest.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.   [ Time Frame: 4 weeks ]

2.  Secondary:   Change in Prostate Volume From Baseline at Week 4   [ Time Frame: 4 weeks ]

3.  Secondary:   Change in Qmax From Baseline at Week 4   [ Time Frame: 4 weeks ]

4.  Secondary:   Categorical Change in Qmax From Baseline at Week 4   [ Time Frame: 4 weeks ]

5.  Secondary:   Percent Change in Qmax From Baseline at Week 4   [ Time Frame: 4 weeks ]

6.  Secondary:   Change in Void Volume From Baseline at Week 4   [ Time Frame: 4 weeks ]

7.  Secondary:   Change in Post-Void Residual Volume From Baseline at Week 4   [ Time Frame: 4 weeks ]

8.  Secondary:   Change in in Dihydrotestosterone Concentration From Baseline at Week 4   [ Time Frame: 4 weeks ]

9.  Secondary:   Change in Luteinizing Hormone Concentration From Baseline at Week 4   [ Time Frame: 4 weeks ]

10.  Secondary:   Change in Total Testosterone Concentration From Baseline at Week 4   [ Time Frame: 4 weeks ]

11.  Secondary:   Participants Assessment of Nocturia at Week 4   [ Time Frame: 4 weeks ]

12.  Secondary:   Investigators Assessment of Nocturia at Week 4   [ Time Frame: 4 weeks ]

13.  Secondary:   Change in I-PSS Total Score From Baseline at Week 4   [ Time Frame: 4 weeks ]

14.  Secondary:   Change in DAN Prostate Symptom Scale From Baseline at Week 4   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rick Schwen, PhD, DABT, RAC / Vice President of Regulatory Affairs
Organization: Ausio Pharmaceuticals, LLC
phone: 513-731-0222
e-mail: rick@ausiopharma.com



Responsible Party: Ausio Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00962390     History of Changes
Other Study ID Numbers: AUS CT04
Study First Received: August 19, 2009
Results First Received: January 18, 2017
Last Updated: April 12, 2017