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Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729469
First Posted: August 7, 2008
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
Results First Submitted: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Atrophy
Vaginal Diseases
Interventions: Drug: Ospemifene 60 mg
Drug: Placebo
Drug: Non-hormonal vaginal lubricant

  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
First patient was screened on August 04, 2008 and last patient completed on July 30, 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS

Reporting Groups
  Description
Subjects on Placebo Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.

Participant Flow:   Overall Study
    Subjects on Placebo   Subjects on Ospemifene 60 mg/Day
STARTED   456   463 
COMPLETED   403   416 
NOT COMPLETED   53   47 
Adverse Event                14                25 
Lost to Follow-up                9                9 
Protocol Violation                2                1 
Withdrawal by Subject                19                8 
Other-Not mentioned                9                4 



  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 received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Total Total of all reporting groups

Baseline Measures
   Subjects on Placebo   Subjects on Ospemifene 60 mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 456   463   919 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.5  (6.39)   58.7  (6.56)   58.6  (6.47) 
Age, Customized 
[Units: Participants]
     
<45   7   8   15 
45-54   106   113   219 
55-64   266   260   526 
>=65   77   82   159 
Gender 
[Units: Participants]
     
Female   456   463   919 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   396   409   805 
Black or African American   35   28   63 
Asian   3   8   11 
Pacific Islander   0   2   2 
Other   22   16   38 
Height 
[Units: Cm]
Mean (Standard Deviation)
 162.6  (6.39)   162.3  (6.34)   162.5  (6.36) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 69.38  (12.38)   68.98  (12.38)   69.18  (12.37) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.21  (4.32)   26.16  (4.31)   26.18  (4.31) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)   [ Time Frame: 12 weeks ]

2.  Primary:   Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)   [ Time Frame: 12 weeks ]

3.  Primary:   Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)   [ Time Frame: 12 weeks ]

4.  Primary:   Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)   [ Time Frame: 12 weeks ]

5.  Primary:   Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)   [ Time Frame: 12 weeks ]

6.  Primary:   Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)   [ Time Frame: 12 weeks ]

7.  Primary:   Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)   [ Time Frame: 12 weeks ]

8.  Primary:   Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)   [ Time Frame: 12 weeks ]

9.  Secondary:   Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)   [ Time Frame: 4 weeks ]

10.  Secondary:   Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)   [ Time Frame: 4 weeks ]

11.  Secondary:   Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)   [ Time Frame: 4 weeks ]

12.  Secondary:   Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)   [ Time Frame: 4 weeks ]

13.  Secondary:   Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)   [ Time Frame: 4 weeks ]

14.  Secondary:   Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)   [ Time Frame: 4 weeks ]

15.  Secondary:   Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)   [ Time Frame: 4 weeks ]

16.  Secondary:   Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)   [ Time Frame: 4 weeks ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT00729469     History of Changes
Other Study ID Numbers: 15-50821
First Submitted: August 4, 2008
First Posted: August 7, 2008
Results First Submitted: March 19, 2013
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013