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Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

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ClinicalTrials.gov Identifier: NCT01586364
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : June 28, 2013
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
QuatRx Pharmaceuticals
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Atrophy
Vaginal Diseases
Intervention: Drug: Ospemifene 60Mg Oral Tablet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Treatment Arm = 60 mg Ospemifene Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks

Participant Flow:   Overall Study
    Treatment Arm = 60 mg Ospemifene
STARTED   301 
COMPLETED   184 
NOT COMPLETED   117 
Withdrawal by Subject                40 
Adverse Event                37 
Lost to Follow-up                17 
Protocol Violation                16 
Lack of Efficacy                1 
Other-Did not feel better post-treatment                1 
Other-Subject wasn't getting much relief                1 
Other-Site closure due to PI illness                1 
Other-PI discretion, site closing                2 
Other-Not specified                1 



  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
Treatment Arm = 60 mg Ospemifene Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks

Baseline Measures
   Treatment Arm = 60 mg Ospemifene 
Overall Participants Analyzed 
[Units: Participants]
 301 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.4  (6.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      301 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      21   7.0% 
Not Hispanic or Latino      280  93.0% 
Unknown or Not Reported      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   278 
Black or African American   11 
Asian   6 
American Indian or Alaska Native   3 
Other   3 
Height 
[Units: Cm]
Mean (Standard Deviation)
 161.90  (6.026) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 70.54  (13.024) 
Body mass index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.865  (4.4106) 


  Outcome Measures

1.  Primary:   Incidence of Adverse Events (AEs)   [ Time Frame: Week 13 (Phone Contact) to Week 56 (Visit 4) ]

2.  Primary:   Change From Baseline in Serum Lipid Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

3.  Primary:   Change From Baseline in Serum Lipid Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

4.  Primary:   Change From Baseline in Blood Pressure at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

5.  Primary:   Change From Baseline in Pulse Rate at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

6.  Primary:   Change From Baseline in Weight at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

7.  Primary:   Change From Baseline in Body Mass Index (BMI) at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

8.  Primary:   Change From Baseline in Blood Pressure at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

9.  Primary:   Change From Baseline in Pulse Rate at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

10.  Primary:   Change From Baseline in Weight at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

11.  Primary:   Change From Baseline in BMI at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

12.  Primary:   Change From Baseline in Visual Evaluation of Vagina at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

13.  Primary:   Change From Baseline in Visual Evaluation of Vagina at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

14.  Primary:   Assessment of Cervical Pap Smear Samples (if Cervix is Intact)   [ Time Frame: Week 52 (Visit 3) ]

15.  Primary:   Assessment of Breast Palpation at Visit 2   [ Time Frame: Week 26 (Visit 2) ]

16.  Primary:   Assessment of Breast Palpation at Visit 3   [ Time Frame: Week 52 (Visit 3) ]

17.  Primary:   Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

18.  Primary:   Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

19.  Primary:   Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

20.  Primary:   Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

21.  Primary:   Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

22.  Primary:   Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

23.  Primary:   Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

24.  Primary:   Change From Baseline in Erythrocyte Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

25.  Primary:   Change From Baseline in Hemoglobin Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

26.  Primary:   Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

27.  Primary:   Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

28.  Primary:   Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

29.  Primary:   Change From Baseline in Erythrocyte Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

30.  Primary:   Change From Baseline in Hemoglobin Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

31.  Primary:   Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

32.  Primary:   Change From Baseline in MCV and MPV at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

33.  Primary:   Change From Baseline in Albumin and Total Protein Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

34.  Primary:   Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

35.  Primary:   Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

36.  Primary:   Change From Baseline in Albumin and Total Protein Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

37.  Primary:   Change From Baseline in ALT, AST and CK Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

38.  Primary:   Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

39.  Primary:   Change From Baseline in pH of Urine at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

40.  Primary:   Change From Baseline in Specific Gravity of Urine at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

41.  Primary:   Change From Baseline in pH of Urine at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

42.  Primary:   Change From Baseline in Specific Gravity of Urine at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

43.  Primary:   Change From Baseline in Estradiol (E2) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

44.  Primary:   Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

45.  Primary:   Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

46.  Primary:   Change From Baseline in Testosterone Levels at Visit 2   [ Time Frame: Baseline to Week 26 (Visit 2) ]

47.  Primary:   Change From Baseline in E2 Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

48.  Primary:   Change From Baseline in FSH and LH Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

49.  Primary:   Change From Baseline in SHBG Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]

50.  Primary:   Change From Baseline in Testosterone Levels at Visit 3   [ Time Frame: Baseline to Week 52 (Visit 3) ]


  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 ext 1454
e-mail: shionogiclintrialsadmin@shionogi.com



Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT01586364     History of Changes
Other Study ID Numbers: 15-50312
First Submitted: April 18, 2012
First Posted: April 26, 2012
Results First Submitted: March 20, 2013
Results First Posted: June 28, 2013
Last Update Posted: May 21, 2018