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A Clinical Study to Evaluate the Safety of Ospemifene

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ClinicalTrials.gov Identifier: NCT00566982
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : June 28, 2013
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrophy
Vaginal Diseases
Interventions: Drug: Ospemifene 60 mg
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a multicenter study conducted at 23 centers in Belgium, Denmark, Finland, and Sweden. First subject was screened on Nov. 26, 2007 and last subjected completed the study on June 26, 2009

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
Subjects on Placebo (Baseline) Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Subjects on Ospemifene 60 mg/Day (Baseline) Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.

Participant Flow:   Overall Study
    Subjects on Placebo (Baseline)   Subjects on Ospemifene 60 mg/Day (Baseline)
STARTED   63   363 
COMPLETED   55   294 
NOT COMPLETED   8   69 
Adverse Event                6                48 
Withdrawal by Subject                1                14 
Protocol Violation                1                4 
Lost to Follow-up                0                1 
Other-family problems & doctor's request                0                2 



  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
Subjects on Ospemifene 60 mg/Day (Baseline) Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Subjects on Placebo (Baseline) Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Total Total of all reporting groups

Baseline Measures
   Subjects on Ospemifene 60 mg/Day (Baseline)   Subjects on Placebo (Baseline)   Total 
Overall Participants Analyzed 
[Units: Participants]
 363   63   426 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (6.16)   62.9  (6.47)   62.3  (6.32) 
Age 
[Units: Years]
Mean (Full Range)
 61.7 
 (49 to 78) 
 62.9 
 (50 to 79) 
 62.3 
 (49 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      363 100.0%      63 100.0%      426 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   361   63   424 
Black   1   0   1 
Asian   1   0   1 
Region of Enrollment 
[Units: Participants]
     
Belgium   101   18   119 
Denmark   56   9   65 
Finland   177   31   208 
Sweden   29   5   34 
Alcohol 
[Units: Drinks/week]
Mean (Standard Deviation)
 2.4  (3.40)   2.3  (3.26)   2.35  (3.33) 
Alcohol 
[Units: Drinks/week]
Mean (Full Range)
 2.4 
 (0 to 14) 
 2.3 
 (0 to 14) 
 2.35 
 (0 to 14) 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.65  (2.916)   24.11  (2.867)   24.38  (2.892) 
BMI 
[Units: Kg/m^2]
Mean (Full Range)
 24.65 
 (17.4 to 31.2) 
 24.11 
 (17.7 to 29.7) 
 24.38 
 (17.4 to 31.2) 


  Outcome Measures

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

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

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

4.  Secondary:   Change From Baseline in Estradiol Levels   [ Time Frame: 52 weeks ]

5.  Secondary:   Change From Baseline in Luteinizing Hormone Levels   [ Time Frame: 52 weeks ]

6.  Secondary:   Change From Baseline in Follicle Stimulating Hormone Levels   [ Time Frame: 52 weeks ]

7.  Secondary:   Change From Baseline in Sex Hormone Binding Globulin Levels   [ Time Frame: 52 weeks ]

8.  Secondary:   Visual Evaluation of the Vagina (Baseline & Week 52)   [ Time Frame: 52 weeks ]


  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
No text entered.


  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 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
e-mail: Shionogiclintrials-admin@shionogi.co.jp



Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT00566982     History of Changes
Other Study ID Numbers: 15-50718
First Submitted: November 30, 2007
First Posted: December 4, 2007
Results First Submitted: March 19, 2013
Results First Posted: June 28, 2013
Last Update Posted: May 18, 2018