A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT00630539
First received: February 28, 2008
Last updated: May 21, 2013
Last verified: March 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrophy
Vaginal Diseases
Interventions: Drug: Placebo
Drug: Ospemifene 5 mg
Drug: Ospemifene 15 mg
Drug: Ospemifene 30 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 9 centers in Finland. First patient was enrolled on August 09, 2007 and last patient completed on February 11, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study population included postmenopausal women 40 to 80 years of age with a diagnosis of vulvar and vaginal atrophy (VVA) assessed by the maturation index (MI) of vaginal smear and vaginal pH at baseline

Reporting Groups
  Description
Subjects on Placebo Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 5 mg/Day Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 15 mg/Day Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 30 mg/Day Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Participant Flow:   Overall Study
    Subjects on Placebo     Subjects on Ospemifene 5 mg/Day     Subjects on Ospemifene 15 mg/Day     Subjects on Ospemifene 30 mg/Day  
STARTED     34     33     29     30  
COMPLETED     33     29     28     27  
NOT COMPLETED     1     4     1     3  
Adverse Event                 1                 3                 1                 2  
Withdrawal by Subject                 0                 1                 0                 1  



  Baseline Characteristics
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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
Subjects on Placebo Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 5 mg/Day Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 15 mg/Day Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects on Ospemifene 30 mg/Day Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Subjects on Placebo     Subjects on Ospemifene 5 mg/Day     Subjects on Ospemifene 15 mg/Day     Subjects on Ospemifene 30 mg/Day     Total  
Number of Participants  
[units: participants]
  34     33     29     30     126  
Age  
[units: years]
Mean ± Standard Deviation
  62.8  ± 6.0     61.5  ± 5.6     63.4  ± 7.1     62.0  ± 6.8     62.4  ± 6.4  
Gender  
[units: participants]
         
Female     34     33     29     30     126  
Male     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
         
Participants     34     33     29     30     126  
Weight  
[units: kg]
Mean ± Standard Deviation
  69.6  ± 10.1     66.5  ± 10.6     68.7  ± 13.5     65.9  ± 7.4     67.7  ± 10.4  
Height  
[units: m]
Mean ± Standard Deviation
  1.609  ± 0.049     1.636  ± .051     1.641  ± .062     1.617  ± .058     1.626  ± 0.055  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  26.89  ± 3.95     24.78  ± 3.44     25.50  ± 4.99     25.28  ± 3.20     25.61  ± 3.90  
Alcohol  
[units: drinks/week]
Mean ± Standard Deviation
  0.9  ± 1.9     1.8  ± 2.4     1.2  ± 1.7     1.5  ± 2.3     1.4  ± 2.1  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear   [ Time Frame: 12 weeks ]

2.  Primary:   Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear   [ Time Frame: 12 weeks ]

3.  Primary:   Mean Change From Baseline in Vaginal pH   [ Time Frame: 12 weeks ]

4.  Secondary:   Visual Evaluation of Vagina (by Gynecological Examination)   [ Time Frame: Screening & Week 12 ]

5.  Secondary:   Mean Change From Baseline in Vaginal pH   [ Time Frame: Week 4 ]

6.  Secondary:   Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index   [ Time Frame: Week 4 ]

7.  Secondary:   Mean Change From Baseline in Estradiol Levels   [ Time Frame: Week 12 ]

8.  Secondary:   Mean Change From Baseline in Luteinizing Hormone Levels   [ Time Frame: Week 12 ]

9.  Secondary:   Mean Change From Baseline in Follicle Stimulating Hormone Levels   [ Time Frame: Week 12 ]

10.  Secondary:   Mean Change From Baseline in Sex Hormone Binding Globulin Levels   [ Time Frame: Week 12 ]

11.  Secondary:   Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index   [ Time Frame: Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi Inc.
phone: 800-849-9707 ext 1454
e-mail: shionogiclintrialsadmin@shionogi.com


No publications provided


Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00630539     History of Changes
Other Study ID Numbers: 15-50717
Study First Received: February 28, 2008
Results First Received: March 19, 2013
Last Updated: May 21, 2013
Health Authority: Sweden: Institutional Review Board
United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Dataprotection Agency
Finland: Ethics Committee