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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

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.
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
Enrollment 301
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Period Title: Overall Study
Started 301
Completed 184
Not Completed 117
Reason Not Completed
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
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Baseline Participants 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants
59.4  (6.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants
Female
301
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants
Hispanic or Latino
21
   7.0%
Not Hispanic or Latino
280
  93.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants
White 278
Black or African American 11
Asian 6
American Indian or Alaska Native 3
Other 3
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 301 participants
161.90  (6.026)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 301 participants
70.54  (13.024)
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 301 participants
26.865  (4.4106)
1.Primary Outcome
Title Incidence of Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Week 13 (Phone Contact) to Week 56 (Visit 4)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 301
Measure Type: Number
Unit of Measure: Participants
Treatment-Emergent AE 220
Related AE (Possibly/Probably/Definitely Related) 67
AE Causing Study Drug Discontinuation 34
Serious AE 13
Severe AE 38
2.Primary Outcome
Title Change From Baseline in Serum Lipid Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 241
Mean (Standard Deviation)
Unit of Measure: percent change
Total Cholesterol 1.59  (17.772)
Low-density lipoprotein cholesterol (LDL-C) 2.83  (29.420)
High-density lipoprotein cholesterol (HDL-C) 2.81  (16.009)
Triglycerides 11.51  (43.422)
3.Primary Outcome
Title Change From Baseline in Serum Lipid Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: percent change
Total Cholesterol -0.02  (16.025)
LDL-C -0.54  (22.932)
HDL-C 2.74  (15.226)
Triglycerides 13.07  (43.877)
4.Primary Outcome
Title Change From Baseline in Blood Pressure at Visit 2
Hide Description Systolic blood pressure (SBP), diastolic blood pressure (DBP)
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 244
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP -1.2  (15.91)
DBP -0.7  (9.32)
5.Primary Outcome
Title Change From Baseline in Pulse Rate at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 244
Mean (Standard Deviation)
Unit of Measure: bpm
2.1  (10.22)
6.Primary Outcome
Title Change From Baseline in Weight at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 244
Mean (Standard Deviation)
Unit of Measure: kg
0.798  (3.6022)
7.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 244
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.309  (1.3628)
8.Primary Outcome
Title Change From Baseline in Blood Pressure at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP -1.2  (16.35)
DBP -1.0  (9.88)
9.Primary Outcome
Title Change From Baseline in Pulse Rate at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: bpm
3.3  (9.43)
10.Primary Outcome
Title Change From Baseline in Weight at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: kg
1.122  (8.2464)
11.Primary Outcome
Title Change From Baseline in BMI at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.439  (3.2779)
12.Primary Outcome
Title Change From Baseline in Visual Evaluation of Vagina at Visit 2
Hide Description Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: units on a scale
Petechiae -0.6  (0.86)
Pallor -1.0  (0.95)
Friability -0.8  (0.89)
Vaginal Dryness in Mucosa -1.4  (0.87)
Vaginal Redness in Mucosa -0.6  (0.92)
13.Primary Outcome
Title Change From Baseline in Visual Evaluation of Vagina at Visit 3
Hide Description Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 198
Mean (Standard Deviation)
Unit of Measure: units on a scale
Petechiae -0.6  (0.90)
Pallor -1.2  (0.95)
Friability -0.8  (0.91)
Vaginal Dryness in Mucosa -1.5  (0.88)
Vaginal Redness in Mucosa -0.8  (0.89)
14.Primary Outcome
Title Assessment of Cervical Pap Smear Samples (if Cervix is Intact)
Hide Description Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.
Time Frame Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
Atypical Squamous Cells-Undetermined Significance 1
Negative for Intraepithelial Lesion or Malignancy 15
15.Primary Outcome
Title Assessment of Breast Palpation at Visit 2
Hide Description Breast palpation was used to assess breast abnormalities.
Time Frame Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Measure Type: Number
Unit of Measure: Participants
Normal 243
Abnormal 0
16.Primary Outcome
Title Assessment of Breast Palpation at Visit 3
Hide Description Breast palpation was used to assess breast abnormalities.
Time Frame Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: Participants
Normal 198
Abnormal 1
17.Primary Outcome
Title Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 242
Mean (Standard Deviation)
Unit of Measure: percent change
Antithrombin Antigen, Plasma 0.4  (10.70)
Protein C Antigen, Plasma -1.3  (21.62)
Protein S Antigen, Free, Plasma 9.6  (15.19)
18.Primary Outcome
Title Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 242
Mean (Standard Deviation)
Unit of Measure: s
-1.5  (14.36)
19.Primary Outcome
Title Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 242
Mean (Standard Deviation)
Unit of Measure: mg/dL
-25.4  (80.30)
20.Primary Outcome
Title Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 194
Mean (Standard Deviation)
Unit of Measure: percent change
Antithrombin Antigen, Plasma 2.4  (10.80)
Protein C Antigen, Plasma 4.3  (22.57)
Protein S Antigen, Free, Plasma 12.9  (20.40)
21.Primary Outcome
Title Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 194
Mean (Standard Deviation)
Unit of Measure: s
-0.7  (17.24)
22.Primary Outcome
Title Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 194
Mean (Standard Deviation)
Unit of Measure: mg/dL
-29.9  (77.19)
23.Primary Outcome
Title Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: (x10(9)/L)
Leukocytes -0.17  (1.201)
Lymphocytes -0.058  (0.4025)
Monocytes -0.012  (0.1557)
Platelet Count -6.2  (41.68)
24.Primary Outcome
Title Change From Baseline in Erythrocyte Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: (x10(12)/L)
-0.098  (0.2454)
25.Primary Outcome
Title Change From Baseline in Hemoglobin Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.29  (0.705)
26.Primary Outcome
Title Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: percent change
Hematocrit -0.86  (2.151)
RBC distribution width 0.07  (0.776)
27.Primary Outcome
Title Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: fL
MCV, free 0.02  (1.732)
MPV 0.01  (0.521)
28.Primary Outcome
Title Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: (x10(9)/L)
Leukocytes -0.05  (1.270)
Lymphocytes -0.010  (0.4410)
Monocytes -0.021  (0.1619)
Platelet Count -13.5  (36.92)
29.Primary Outcome
Title Change From Baseline in Erythrocyte Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: (x10(12)/L)
-0.108  (0.2745)
30.Primary Outcome
Title Change From Baseline in Hemoglobin Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.35  (0.840)
31.Primary Outcome
Title Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: percent change
Hematocrit -0.97  (2.490)
RBC distribution width 0.14  (0.834)
32.Primary Outcome
Title Change From Baseline in MCV and MPV at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: fL
MCV, free 0.01  (2.081)
MPV -0.03  (0.512)
33.Primary Outcome
Title Change From Baseline in Albumin and Total Protein Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: g/dL
Albumin, Serum -0.10  (0.248)
Total Protein, Serum -0.14  (0.399)
34.Primary Outcome
Title Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: U/L
ALT, Serum -3.7  (10.93)
AST, Serum -0.1  (5.62)
CK, Serum -6.7  (46.23)
35.Primary Outcome
Title Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: mg/dL
Bilirubin Total, Serum -0.08  (0.144)
Creatinine, Plasma/Serum -0.06  (0.125)
Glucose, Plasma/Serum 3.2  (17.75)
Uric Acid, Serum -0.02  (0.786)
BUN 0.5  (3.86)
36.Primary Outcome
Title Change From Baseline in Albumin and Total Protein Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
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The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: g/dL
Albumin, Serum -0.08  (0.232)
Total Protein, Serum -0.19  (0.376)
37.Primary Outcome
Title Change From Baseline in ALT, AST and CK Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: U/L
ALT, Serum -4.1  (11.81)
AST, Serum 0.2  (7.06)
CK, Serum 2.6  (109.35)
38.Primary Outcome
Title Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: mg/dL
Bilirubin Total, Serum -0.08  (0.151)
Creatinine, Plasma/Serum -0.04  (0.125)
Glucose, Plasma/Serum 3.6  (16.47)
Uric Acid, Serum 0.03  (0.792)
BUN 0.7  (4.15)
39.Primary Outcome
Title Change From Baseline in pH of Urine at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
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Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 239
Mean (Standard Deviation)
Unit of Measure: pH
-0.11  (1.065)
40.Primary Outcome
Title Change From Baseline in Specific Gravity of Urine at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 239
Mean (Standard Deviation)
Unit of Measure: units
0.0003  (0.00672)
41.Primary Outcome
Title Change From Baseline in pH of Urine at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: pH
-0.09  (1.118)
42.Primary Outcome
Title Change From Baseline in Specific Gravity of Urine at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units
-0.0010  (0.00695)
43.Primary Outcome
Title Change From Baseline in Estradiol (E2) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.5  (4.71)
44.Primary Outcome
Title Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: IU/L
FSH -10.3  (14.13)
LH -2.2  (6.86)
45.Primary Outcome
Title Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: nmol/L
19.5  (22.67)
46.Primary Outcome
Title Change From Baseline in Testosterone Levels at Visit 2
Hide Description [Not Specified]
Time Frame Baseline to Week 26 (Visit 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 243
Mean (Standard Deviation)
Unit of Measure: ng/dL
Testosterone, Free -0.03  (0.125)
Testosterone, Total 1.45  (5.108)
47.Primary Outcome
Title Change From Baseline in E2 Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.4  (10.28)
48.Primary Outcome
Title Change From Baseline in FSH and LH Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: IU/L
FSH -15.9  (13.57)
LH -1.7  (6.70)
49.Primary Outcome
Title Change From Baseline in SHBG Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: nmol/L
20.1  (23.19)
50.Primary Outcome
Title Change From Baseline in Testosterone Levels at Visit 3
Hide Description [Not Specified]
Time Frame Baseline to Week 52 (Visit 3)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description:
Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
Overall Number of Participants Analyzed 196
Mean (Standard Deviation)
Unit of Measure: ng/dL
Testosterone, Free 0.00  (0.124)
Testosterone, Total 2.23  (5.177)
Time Frame 56 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm = 60 mg Ospemifene
Hide Arm/Group Description Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
All-Cause Mortality
Treatment Arm = 60 mg Ospemifene
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm = 60 mg Ospemifene
Affected / at Risk (%)
Total   13/301 (4.32%) 
Cardiac disorders   
Acute Myocardial Infarction  1  1/301 (0.33%) 
General disorders   
Non-Cardiac Chest Pain  1  1/301 (0.33%) 
Infections and infestations   
Diverticulitis  1  1/301 (0.33%) 
Injury, poisoning and procedural complications   
Intentional Overdose  1  1/301 (0.33%) 
Overdose  1  1/301 (0.33%) 
Musculoskeletal and connective tissue disorders   
Intervertebral Disc Protrusion  1  1/301 (0.33%) 
Lumbar Spinal Stenosis  1  1/301 (0.33%) 
Osteoarthritis  1  1/301 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anal Cancer  1  1/301 (0.33%) 
Spinal Meningioma Benign  1  1/301 (0.33%) 
Transitional Cell Carcinoma  1  1/301 (0.33%) 
Nervous system disorders   
Haemorrahagic Stroke  1  1/301 (0.33%) 
Hypoaesthesia  1  1/301 (0.33%) 
Syncope  1  1/301 (0.33%) 
Psychiatric disorders   
Anxiety Disorder  1  1/301 (0.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/301 (0.33%) 
Vascular disorders   
Thrombophlebitis Superficial  1  1/301 (0.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm = 60 mg Ospemifene
Affected / at Risk (%)
Total   74/301 (24.58%) 
Infections and infestations   
Sinusitis  1  24/301 (7.97%) 
Urinary Tract Infection  1  26/301 (8.64%) 
Vascular disorders   
Hot Flush  1  31/301 (10.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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 sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Results Point of Contact
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi Inc.
Phone: 800-849-9707 ext 1454
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