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Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients

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ClinicalTrials.gov Identifier: NCT00962585
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ausio Pharmaceuticals, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Menopause
Interventions: Drug: Placebo
Drug: S-equol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients for this trial were screened from 9 investigative sites in the United States and Australia. Participants were women of menopausal status and experiencing vasomotor symptoms and nocturnal sweating.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After completing screening visit assessments, subjects were instructed to refrain from taking prohibited medications throughout the study. Patients who were taking prohibited medications at the time of the screening visit discontinued their use and completed a suitable washout period before progressing to the next visit.

Reporting Groups
  Description
S-equol 10 mg BID 20 mg total daily dose of S-equol
S-equol 50 mg BID 100 mg total daily dose of S-equol
S-equol 150 mg BID 300 mg total daily dose of S-equol
Placebo Placebo treatment arm

Participant Flow:   Overall Study
    S-equol 10 mg BID   S-equol 50 mg BID   S-equol 150 mg BID   Placebo
STARTED   43   42   42   42 
COMPLETED   37   40   39   42 
NOT COMPLETED   6   2   3   0 
Adverse Event                0                2                1                0 
Lost to Follow-up                3                0                1                0 
Protocol Violation                0                0                1                0 
Withdrawal by Subject                1                0                0                0 
Withdrew Consent                2                0                0                0 



  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.
No text entered.

Reporting Groups
  Description
S-equol 10 mg BID 20 mg total daily dose of S-equol
S-equol 50 mg BID 100 mg total daily dose of S-equol
S-equol 150 mg BID 300 mg total daily dose of S-equol
Placebo Placebo treatment arm
Total Total of all reporting groups

Baseline Measures
   S-equol 10 mg BID   S-equol 50 mg BID   S-equol 150 mg BID   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   42   42   42   169 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 53.8  (7.9)   53.1  (6.9)   54.9  (5.8)   56.2  (6.7)   54.5  (6.9) 
Gender 
[Units: Participants]
         
Female   43   42   42   42   169 
Male   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   0   0   0   1   1 
Black or African American   4   7   10   5   26 
White   39   35   32   34   140 
Unknown or Not Reported   0   0   0   2   2 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 165.3  (5.1)   164.1  (4.6)   165.4  (6.7)   163.3  (5.9)   164.5  (5.6) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 74.1  (11.6)   73.0  (10.7)   74.4  (10.1)   73.2  (12.8)   73.7  (11.3) 
Body Mass Index 
[Units: Kilogram/meter^2]
Mean (Standard Deviation)
 27.1  (3.9)   27.1  (4.1)   27.2  (3.5)   27.4  (4.1)   27.2  (3.9) 


  Outcome Measures

1.  Primary:   Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period)   [ Time Frame: 4 weeks from Baseline (2-week run-in period) ]

2.  Secondary:   Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period)   [ Time Frame: 4 weeks from Baseline (period following first 7 days of 2-week run-in period) ]

3.  Secondary:   Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2   [ Time Frame: 1 and 2 weeks from Baseline (Day 0) ]

4.  Secondary:   Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4   [ Time Frame: 1, 2, and 4 weeks from Baseline (Day 0) ]

5.  Secondary:   Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4   [ Time Frame: 2 and 4 weeks from Baseline (Day 0) ]

6.  Secondary:   Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4   [ Time Frame: 2 and 4 weeks from Baseline (Day 0) ]

7.  Secondary:   Change From Baseline in Estradiol Concentration at Weeks 2 and 4   [ Time Frame: 2 and 4 weeks from Baseline (Day 0) ]

8.  Secondary:   Change From Baseline in Progesterone Concentration at Week 2 and Week 4   [ Time Frame: 2 and 4 weeks from Baseline (Day 0) ]

9.  Secondary:   Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4   [ Time Frame: 4 weeks from Baseline (Day 0) ]

10.  Secondary:   Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4   [ Time Frame: 4 weeks from Baseline (Day 0) ]

11.  Post-Hoc:   Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)   [ Time Frame: 4 weeks from Baseline (Day 0) ]

12.  Post-Hoc:   Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)   [ Time Frame: 4 weeks from Baseline (Day 0) ]

13.  Post-Hoc:   Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined   [ Time Frame: 4 weeks from Baseline (Day 0) ]

14.  Post-Hoc:   Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined   [ Time Frame: 4 weeks from Baseline (Day 0) ]


  Serious Adverse Events


  Other Adverse Events


  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
Per-protocol, an ANOVA model was to be used for the primary efficacy analysis. However using statistical adjustment of baseline values, ANCOVA could be more a more powerful analysis (Vickers AJ. BMC Med Res Methodology. 2001;1:6. Epub 2001 Jun 28).


  More Information

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: NCT00962585     History of Changes
Other Study ID Numbers: AUS-CT03
First Submitted: August 19, 2009
First Posted: August 20, 2009
Results First Submitted: May 7, 2013
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014