Atrophy, Vaginal Diseases
Conditions
Keywords
Menopausal symptoms, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy, Urogenital atrophy
Brief summary
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
Interventions
DRUGOspemifene 60Mg Oral Tablet
Sponsors
QuatRx Pharmaceuticals
Shionogi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310 * Did not have a uterus * Met the inclusion and
Exclusion criteria
for Protocol 15-50310 * Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310 * Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Lipid Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Incidence of Adverse Events (AEs) | Week 13 (Phone Contact) to Week 56 (Visit 4) | — |
| Change From Baseline in Serum Lipid Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Blood Pressure at Visit 2 | Baseline to Week 26 (Visit 2) | Systolic blood pressure (SBP), diastolic blood pressure (DBP) |
| Change From Baseline in Pulse Rate at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Weight at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Body Mass Index (BMI) at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Blood Pressure at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Pulse Rate at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Weight at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in BMI at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Baseline to Week 26 (Visit 2) | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) |
| Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Baseline to Week 52 (Visit 3) | Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe) |
| Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | Week 52 (Visit 3) | 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. |
| Assessment of Breast Palpation at Visit 2 | Week 26 (Visit 2) | Breast palpation was used to assess breast abnormalities. |
| Assessment of Breast Palpation at Visit 3 | Week 52 (Visit 3) | Breast palpation was used to assess breast abnormalities. |
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Erythrocyte Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Hemoglobin Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Erythrocyte Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Hemoglobin Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in MCV and MPV at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Albumin and Total Protein Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Albumin and Total Protein Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in ALT, AST and CK Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in pH of Urine at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Specific Gravity of Urine at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in pH of Urine at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Specific Gravity of Urine at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Estradiol (E2) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in Testosterone Levels at Visit 2 | Baseline to Week 26 (Visit 2) | — |
| Change From Baseline in E2 Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in FSH and LH Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in SHBG Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
| Change From Baseline in Testosterone Levels at Visit 3 | Baseline to Week 52 (Visit 3) | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm = 60 mg Ospemifene Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks | 301 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 37 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Other-Did not feel better post-treatment | 1 |
| Overall Study | Other-Not specified | 1 |
| Overall Study | Other-PI discretion, site closing | 2 |
| Overall Study | Other-Site closure due to PI illness | 1 |
| Overall Study | Other-Subject wasn't getting much relief | 1 |
| Overall Study | Protocol Violation | 16 |
| Overall Study | Withdrawal by Subject | 40 |
Baseline characteristics
| Characteristic | Treatment Arm = 60 mg Ospemifene |
|---|---|
| Age, Continuous | 59.4 Years STANDARD_DEVIATION 6.74 |
| Body mass index (BMI) | 26.865 kg/m^2 STANDARD_DEVIATION 4.4106 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 161.90 cm STANDARD_DEVIATION 6.026 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 278 Participants |
| Sex: Female, Male Female | 301 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 70.54 kg STANDARD_DEVIATION 13.024 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 74 / 301 |
| serious Total, serious adverse events | 13 / 301 |
Outcome results
Primary
Assessment of Breast Palpation at Visit 2
Breast palpation was used to assess breast abnormalities.
Time frame: Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Assessment of Breast Palpation at Visit 2 | Normal | 243 Participants |
| Treatment Arm = 60 mg Ospemifene | Assessment of Breast Palpation at Visit 2 | Abnormal | 0 Participants |
Primary
Assessment of Breast Palpation at Visit 3
Breast palpation was used to assess breast abnormalities.
Time frame: Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Assessment of Breast Palpation at Visit 3 | Normal | 198 Participants |
| Treatment Arm = 60 mg Ospemifene | Assessment of Breast Palpation at Visit 3 | Abnormal | 1 Participants |
Primary
Assessment of Cervical Pap Smear Samples (if Cervix is Intact)
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | Atypical Squamous Cells-Undetermined Significance | 1 Participants |
| Treatment Arm = 60 mg Ospemifene | Assessment of Cervical Pap Smear Samples (if Cervix is Intact) | Negative for Intraepithelial Lesion or Malignancy | 15 Participants |
Primary
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 | -1.5 s | Standard Deviation 14.36 |
Primary
Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 | -0.7 s | Standard Deviation 17.24 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | ALT, Serum | -3.7 U/L | Standard Deviation 10.93 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | AST, Serum | -0.1 U/L | Standard Deviation 5.62 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | CK, Serum | -6.7 U/L | Standard Deviation 46.23 |
Primary
Change From Baseline in Albumin and Total Protein Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Albumin and Total Protein Levels at Visit 2 | Albumin, Serum | -0.10 g/dL | Standard Deviation 0.248 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Albumin and Total Protein Levels at Visit 2 | Total Protein, Serum | -0.14 g/dL | Standard Deviation 0.399 |
Primary
Change From Baseline in Albumin and Total Protein Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Albumin and Total Protein Levels at Visit 3 | Albumin, Serum | -0.08 g/dL | Standard Deviation 0.232 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Albumin and Total Protein Levels at Visit 3 | Total Protein, Serum | -0.19 g/dL | Standard Deviation 0.376 |
Primary
Change From Baseline in ALT, AST and CK Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in ALT, AST and CK Levels at Visit 3 | ALT, Serum | -4.1 U/L | Standard Deviation 11.81 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in ALT, AST and CK Levels at Visit 3 | AST, Serum | 0.2 U/L | Standard Deviation 7.06 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in ALT, AST and CK Levels at Visit 3 | CK, Serum | 2.6 U/L | Standard Deviation 109.35 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Bilirubin Total, Serum | -0.08 mg/dL | Standard Deviation 0.144 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Creatinine, Plasma/Serum | -0.06 mg/dL | Standard Deviation 0.125 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Glucose, Plasma/Serum | 3.2 mg/dL | Standard Deviation 17.75 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Uric Acid, Serum | -0.02 mg/dL | Standard Deviation 0.786 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | BUN | 0.5 mg/dL | Standard Deviation 3.86 |
Primary
Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Bilirubin Total, Serum | -0.08 mg/dL | Standard Deviation 0.151 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Creatinine, Plasma/Serum | -0.04 mg/dL | Standard Deviation 0.125 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Glucose, Plasma/Serum | 3.6 mg/dL | Standard Deviation 16.47 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Uric Acid, Serum | 0.03 mg/dL | Standard Deviation 0.792 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | BUN | 0.7 mg/dL | Standard Deviation 4.15 |
Primary
Change From Baseline in Blood Pressure at Visit 2
Systolic blood pressure (SBP), diastolic blood pressure (DBP)
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Blood Pressure at Visit 2 | SBP | -1.2 mmHg | Standard Deviation 15.91 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Blood Pressure at Visit 2 | DBP | -0.7 mmHg | Standard Deviation 9.32 |
Primary
Change From Baseline in Blood Pressure at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Blood Pressure at Visit 3 | SBP | -1.2 mmHg | Standard Deviation 16.35 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Blood Pressure at Visit 3 | DBP | -1.0 mmHg | Standard Deviation 9.88 |
Primary
Change From Baseline in BMI at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in BMI at Visit 3 | 0.439 kg/m^2 | Standard Deviation 3.2779 |
Primary
Change From Baseline in Body Mass Index (BMI) at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Body Mass Index (BMI) at Visit 2 | 0.309 kg/m^2 | Standard Deviation 1.3628 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Antithrombin Antigen, Plasma | 0.4 percent change | Standard Deviation 10.7 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Protein C Antigen, Plasma | -1.3 percent change | Standard Deviation 21.62 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Protein S Antigen, Free, Plasma | 9.6 percent change | Standard Deviation 15.19 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Antithrombin Antigen, Plasma | 2.4 percent change | Standard Deviation 10.8 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Protein C Antigen, Plasma | 4.3 percent change | Standard Deviation 22.57 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Protein S Antigen, Free, Plasma | 12.9 percent change | Standard Deviation 20.4 |
Primary
Change From Baseline in E2 Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in E2 Levels at Visit 3 | 0.4 pg/mL | Standard Deviation 10.28 |
Primary
Change From Baseline in Erythrocyte Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Erythrocyte Levels at Visit 2 | -0.098 (x10(12)/L) | Standard Deviation 0.2454 |
Primary
Change From Baseline in Erythrocyte Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Erythrocyte Levels at Visit 3 | -0.108 (x10(12)/L) | Standard Deviation 0.2745 |
Primary
Change From Baseline in Estradiol (E2) Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Estradiol (E2) Levels at Visit 2 | 0.5 pg/mL | Standard Deviation 4.71 |
Primary
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 | -25.4 mg/dL | Standard Deviation 80.3 |
Primary
Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 | -29.9 mg/dL | Standard Deviation 77.19 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | FSH | -10.3 IU/L | Standard Deviation 14.13 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | LH | -2.2 IU/L | Standard Deviation 6.86 |
Primary
Change From Baseline in FSH and LH Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in FSH and LH Levels at Visit 3 | FSH | -15.9 IU/L | Standard Deviation 13.57 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in FSH and LH Levels at Visit 3 | LH | -1.7 IU/L | Standard Deviation 6.7 |
Primary
Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | Hematocrit | -0.97 percent change | Standard Deviation 2.49 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | RBC distribution width | 0.14 percent change | Standard Deviation 0.834 |
Primary
Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | Hematocrit | -0.86 percent change | Standard Deviation 2.151 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | RBC distribution width | 0.07 percent change | Standard Deviation 0.776 |
Primary
Change From Baseline in Hemoglobin Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hemoglobin Levels at Visit 2 | -0.29 g/dL | Standard Deviation 0.705 |
Primary
Change From Baseline in Hemoglobin Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Hemoglobin Levels at Visit 3 | -0.35 g/dL | Standard Deviation 0.84 |
Primary
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Leukocytes | -0.17 (x10(9)/L) | Standard Deviation 1.201 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Lymphocytes | -0.058 (x10(9)/L) | Standard Deviation 0.4025 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Monocytes | -0.012 (x10(9)/L) | Standard Deviation 0.1557 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Platelet Count | -6.2 (x10(9)/L) | Standard Deviation 41.68 |
Primary
Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Leukocytes | -0.05 (x10(9)/L) | Standard Deviation 1.27 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Lymphocytes | -0.010 (x10(9)/L) | Standard Deviation 0.441 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Monocytes | -0.021 (x10(9)/L) | Standard Deviation 0.1619 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Platelet Count | -13.5 (x10(9)/L) | Standard Deviation 36.92 |
Primary
Change From Baseline in MCV and MPV at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in MCV and MPV at Visit 3 | MCV, free | 0.01 fL | Standard Deviation 2.081 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in MCV and MPV at Visit 3 | MPV | -0.03 fL | Standard Deviation 0.512 |
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | MCV, free | 0.02 fL | Standard Deviation 1.732 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | MPV | 0.01 fL | Standard Deviation 0.521 |
Primary
Change From Baseline in pH of Urine at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in pH of Urine at Visit 2 | -0.11 pH | Standard Deviation 1.065 |
Primary
Change From Baseline in pH of Urine at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in pH of Urine at Visit 3 | -0.09 pH | Standard Deviation 1.118 |
Primary
Change From Baseline in Pulse Rate at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Pulse Rate at Visit 2 | 2.1 bpm | Standard Deviation 10.22 |
Primary
Change From Baseline in Pulse Rate at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Pulse Rate at Visit 3 | 3.3 bpm | Standard Deviation 9.43 |
Primary
Change From Baseline in Serum Lipid Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 2 | Total Cholesterol | 1.59 percent change | Standard Deviation 17.772 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 2 | Low-density lipoprotein cholesterol (LDL-C) | 2.83 percent change | Standard Deviation 29.42 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 2 | High-density lipoprotein cholesterol (HDL-C) | 2.81 percent change | Standard Deviation 16.009 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 2 | Triglycerides | 11.51 percent change | Standard Deviation 43.422 |
Primary
Change From Baseline in Serum Lipid Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 3 | Total Cholesterol | -0.02 percent change | Standard Deviation 16.025 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 3 | LDL-C | -0.54 percent change | Standard Deviation 22.932 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 3 | HDL-C | 2.74 percent change | Standard Deviation 15.226 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Serum Lipid Levels at Visit 3 | Triglycerides | 13.07 percent change | Standard Deviation 43.877 |
Primary
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 | 19.5 nmol/L | Standard Deviation 22.67 |
Primary
Change From Baseline in SHBG Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in SHBG Levels at Visit 3 | 20.1 nmol/L | Standard Deviation 23.19 |
Primary
Change From Baseline in Specific Gravity of Urine at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Specific Gravity of Urine at Visit 2 | 0.0003 units | Standard Deviation 0.00672 |
Primary
Change From Baseline in Specific Gravity of Urine at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Specific Gravity of Urine at Visit 3 | -0.0010 units | Standard Deviation 0.00695 |
Primary
Change From Baseline in Testosterone Levels at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Testosterone Levels at Visit 2 | Testosterone, Free | -0.03 ng/dL | Standard Deviation 0.125 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Testosterone Levels at Visit 2 | Testosterone, Total | 1.45 ng/dL | Standard Deviation 5.108 |
Primary
Change From Baseline in Testosterone Levels at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Testosterone Levels at Visit 3 | Testosterone, Free | 0.00 ng/dL | Standard Deviation 0.124 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Testosterone Levels at Visit 3 | Testosterone, Total | 2.23 ng/dL | Standard Deviation 5.177 |
Primary
Change From Baseline in Visual Evaluation of Vagina at Visit 2
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Petechiae | -0.6 units on a scale | Standard Deviation 0.86 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Pallor | -1.0 units on a scale | Standard Deviation 0.95 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Friability | -0.8 units on a scale | Standard Deviation 0.89 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Vaginal Dryness in Mucosa | -1.4 units on a scale | Standard Deviation 0.87 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 2 | Vaginal Redness in Mucosa | -0.6 units on a scale | Standard Deviation 0.92 |
Primary
Change From Baseline in Visual Evaluation of Vagina at Visit 3
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)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Petechiae | -0.6 units on a scale | Standard Deviation 0.9 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Pallor | -1.2 units on a scale | Standard Deviation 0.95 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Friability | -0.8 units on a scale | Standard Deviation 0.91 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Vaginal Dryness in Mucosa | -1.5 units on a scale | Standard Deviation 0.88 |
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Visual Evaluation of Vagina at Visit 3 | Vaginal Redness in Mucosa | -0.8 units on a scale | Standard Deviation 0.89 |
Primary
Change From Baseline in Weight at Visit 2
Time frame: Baseline to Week 26 (Visit 2)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Weight at Visit 2 | 0.798 kg | Standard Deviation 3.6022 |
Primary
Change From Baseline in Weight at Visit 3
Time frame: Baseline to Week 52 (Visit 3)
Population: The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Change From Baseline in Weight at Visit 3 | 1.122 kg | Standard Deviation 8.2464 |
Primary
Incidence of Adverse Events (AEs)
Time frame: Week 13 (Phone Contact) to Week 56 (Visit 4)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm = 60 mg Ospemifene | Incidence of Adverse Events (AEs) | Treatment-Emergent AE | 220 Participants |
| Treatment Arm = 60 mg Ospemifene | Incidence of Adverse Events (AEs) | Related AE (Possibly/Probably/Definitely Related) | 67 Participants |
| Treatment Arm = 60 mg Ospemifene | Incidence of Adverse Events (AEs) | AE Causing Study Drug Discontinuation | 34 Participants |
| Treatment Arm = 60 mg Ospemifene | Incidence of Adverse Events (AEs) | Serious AE | 13 Participants |
| Treatment Arm = 60 mg Ospemifene | Incidence of Adverse Events (AEs) | Severe AE | 38 Participants |