Atrophy, Vaginal Diseases
Conditions
Keywords
Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy
Brief summary
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
Interventions
DRUGOspemifene (Dose 1)
DRUGOspemifene (Dose 2)
DRUGPlacebo
Sponsors
QuatRx Pharmaceuticals
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 * Had an intact uterus * Met the inclusion and
Exclusion criteria
for Protocol 15-50310 * Had completed Protocol 15-50310
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FSH Levels | Baseline to Week 52 (Visit 6) | — |
| Change From Baseline in SHBG Levels | Baseline to Week 52 (Visit 6) | — |
| Assessment of Mammography | Week 52 (Visit 6) | Mammography was done for the detection of characteristic masses and microcalcifications in the breast. |
| Change From Baseline in Antithrombin Antigen, P Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Fibrinogen Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Testosterone (Total) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Testosterone (Free) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in E2 Levels | Baseline to Week 52 (Visit 6) | — |
| Incidence of Adverse Events (AEs) | Week 20 (Phone Contact) to Week 56 (Visit 7) | — |
| Assessment of Cervical Pap Smear Samples | Week 52 (Visit 6) | Cervical Pap smear samples were 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 Endometrial Biopsy | Week 52 (Visit 6) | Assessments were based on Blaustein's classification. |
| Mean Percent Change From Baseline in Serum Lipids | Baseline to Week 26 (Visit 5) | — |
| Mean Change in Blood Chemistry Parameters | Baseline to Week 26 (Visit 5) | — |
| Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | Baseline to Week 26 (Visit 5) | Mean change in endometrial thickness from baseline |
| Assessment of Endometrial Safety With a TVU | Baseline to Week 52 (Visit 6) | Mean change in endometrial thickness from baseline |
| Change From Baseline in Visual Evaluation of the Vagina | Baseline to Week 26 (Visit 5) | Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe). |
| Change From Baseline in Estradiol (E2) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Luteinizing Hormone (LH) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Follicle Stimulating Hormone (FSH) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in LH Levels | Baseline to Week 52 (Visit 6) | — |
| Change From Baseline in Protein C Ag, P Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Protein S Ag (Free), P Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Thromboplastin Time | Baseline to Week 26 (Visit 5) | — |
| Assessment of Breast Palpation | Week 26 (Visit 5) | Breast palpation was done by the investigator to assess abnormalities in the breast. |
| Assessment of Hematology Tests | Baseline to Week 26 (Visit 5) | Change from baseline |
| Change From Baseline in Erythrocyte (RBC) Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Hemogobin Levels | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Hematocrit Levels | Baseline to Week 26 (Visit 5) | — |
| Assessment of Hematology Test Values | Baseline to Week 52 (Visit 6) | Change from baseline |
| Change From Baseline in Hemoglobin Levels | Baseine to Week 52 (Visit 6) | — |
| Change From Baseline in pH of Urine | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Specific Gravtiy of Urine | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Specific Gravity of Urine | Baseline to Week 52 (Visit 6) | — |
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Pulse Rate | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in Weight | Baseline to Week 26 (Visit 5) | — |
| Change From Baseline in BMI | Baseline to Week 26 | — |
| Change From Baseline in SBP | Baseline to Week 52 (Visit 6) | — |
| Change From Baseline in DBP | Baseline to Week 52 (Visit 6) | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ospemifene 30 mg (Dose 1) Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks | 62 |
| Ospemifene 60 mg (Dose 2) Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks | 69 |
| Placebo Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks | 49 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 3 |
| Overall Study | Protocol Violation | 4 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 8 |
Baseline characteristics
| Characteristic | Ospemifene 60 mg (Dose 2) | Total | Placebo | Ospemifene 30 mg (Dose 1) |
|---|---|---|---|---|
| Age, Continuous | 57.7 Years STANDARD_DEVIATION 5.88 | 58.1 Years STANDARD_DEVIATION 5.51 | 58.2 Years STANDARD_DEVIATION 4.02 | 58.4 Years STANDARD_DEVIATION 6.13 |
| Body mass index (BMI) | 24.792 kg/m^2 STANDARD_DEVIATION 4.1292 | 25.282 kg/m^2 STANDARD_DEVIATION 4.0762 | 25.045 kg/m^2 STANDARD_DEVIATION 3.8496 | 26.014 kg/m^2 STANDARD_DEVIATION 4.1507 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 174 Participants | 47 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 162.53 cm STANDARD_DEVIATION 6.488 | 162.84 cm STANDARD_DEVIATION 6.509 | 163.27 cm STANDARD_DEVIATION 6.082 | 162.83 cm STANDARD_DEVIATION 6.93 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 10 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Missing value | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 162 Participants | 43 Participants | 58 Participants |
| Sex: Female, Male Female | 69 Participants | 180 Participants | 49 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 65.52 kg STANDARD_DEVIATION 11.626 | 67.02 kg STANDARD_DEVIATION 11.252 | 66.71 kg STANDARD_DEVIATION 10.482 | 68.92 kg STANDARD_DEVIATION 11.316 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 62 | 21 / 69 | 11 / 49 |
| serious Total, serious adverse events | 2 / 62 | 5 / 69 | 1 / 49 |
Outcome results
Primary
Assessment of Breast Palpation
Breast palpation was done by the investigator to assess abnormalities in the breast.
Time frame: Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Breast Palpation | Normal | 49 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Breast Palpation | Abnormal | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Breast Palpation | Normal | 57 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Breast Palpation | Abnormal | 1 Participants |
| Placebo | Assessment of Breast Palpation | Normal | 35 Participants |
| Placebo | Assessment of Breast Palpation | Abnormal | 0 Participants |
Primary
Assessment of Breast Palpation
Breast palpation was done by the investigator to assess abnormalities in the breast.
Time frame: Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Breast Palpation | Normal | 52 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Breast Palpation | Not done | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Breast Palpation | Abnormal | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Breast Palpation | Normal | 64 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Breast Palpation | Not done | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Breast Palpation | Abnormal | 0 Participants |
| Placebo | Assessment of Breast Palpation | Not done | 0 Participants |
| Placebo | Assessment of Breast Palpation | Abnormal | 1 Participants |
| Placebo | Assessment of Breast Palpation | Normal | 41 Participants |
Primary
Assessment of Cervical Pap Smear Samples
Cervical Pap smear samples were 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 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | ASC-US | 1 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | Inadequate squamous epithelial component | 1 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | Low grade SIL (slight dysplasia and/or HPV effect) | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | Negative for intraepithelial lesion or malignancy | 45 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | Reactive endocervical and/or metaplastic cells | 1 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Cervical Pap Smear Samples | Unsatisfactory: Due to reasons noted | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | Unsatisfactory: Due to reasons noted | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | ASC-US | 2 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | Negative for intraepithelial lesion or malignancy | 54 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | Reactive endocervical and/or metaplastic cells | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | Inadequate squamous epithelial component | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Cervical Pap Smear Samples | Low grade SIL (slight dysplasia and/or HPV effect) | 1 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | Inadequate squamous epithelial component | 1 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | Low grade SIL (slight dysplasia and/or HPV effect) | 0 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | Unsatisfactory: Due to reasons noted | 0 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | Negative for intraepithelial lesion or malignancy | 33 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | ASC-US | 0 Participants |
| Placebo | Assessment of Cervical Pap Smear Samples | Reactive endocervical and/or metaplastic cells | 0 Participants |
Primary
Assessment of Endometrial Biopsy
Assessments were based on Blaustein's classification.
Time frame: Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Atrophic/inactive/insufficient | 44 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Weakly proliferative | 1 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Atypical epithelial proliferation | 1 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Proliferative pattern, disordered type | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Other (Polyp, atrophic type) | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Biopsy | Hyperplasia or carcinoma | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Hyperplasia or carcinoma | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Atrophic/inactive/insufficient | 53 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Proliferative pattern, disordered type | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Other (Polyp, atrophic type) | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Weakly proliferative | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Biopsy | Atypical epithelial proliferation | 0 Participants |
| Placebo | Assessment of Endometrial Biopsy | Weakly proliferative | 0 Participants |
| Placebo | Assessment of Endometrial Biopsy | Atypical epithelial proliferation | 0 Participants |
| Placebo | Assessment of Endometrial Biopsy | Hyperplasia or carcinoma | 0 Participants |
| Placebo | Assessment of Endometrial Biopsy | Proliferative pattern, disordered type | 0 Participants |
| Placebo | Assessment of Endometrial Biopsy | Atrophic/inactive/insufficient | 32 Participants |
| Placebo | Assessment of Endometrial Biopsy | Other (Polyp, atrophic type) | 0 Participants |
Primary
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
Mean change in endometrial thickness from baseline
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | 0.580 mm | Standard Deviation 1.9041 |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | 0.818 mm | Standard Deviation 1.6689 |
| Placebo | Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | -0.119 mm | Standard Deviation 1.1629 |
Primary
Assessment of Endometrial Safety With a TVU
Mean change in endometrial thickness from baseline
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Endometrial Safety With a TVU | 0.681 mm | Standard Deviation 2.5666 |
| Ospemifene 60 mg (Dose 2) | Assessment of Endometrial Safety With a TVU | 1.139 mm | Standard Deviation 1.5568 |
| Placebo | Assessment of Endometrial Safety With a TVU | -0.041 mm | Standard Deviation 1.1455 |
Primary
Assessment of Hematology Tests
Change from baseline
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Basophils | 0.006 (x10(9)/L) | Standard Deviation 0.024 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Neutrophils | -0.010 (x10(9)/L) | Standard Deviation 0.9812 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Monocytes | 0.025 (x10(9)/L) | Standard Deviation 0.1297 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Leukocytes (WBC) | -0.008 (x10(9)/L) | Standard Deviation 1.2147 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Platelet Count | -5.2 (x10(9)/L) | Standard Deviation 31.23 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Eosinophils | -0.010 (x10(9)/L) | Standard Deviation 0.0955 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Tests | Lymphocytes | -0.035 (x10(9)/L) | Standard Deviation 0.3169 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Monocytes | -0.042 (x10(9)/L) | Standard Deviation 0.1127 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Leukocytes (WBC) | -0.211 (x10(9)/L) | Standard Deviation 1.3608 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Basophils | 0.001 (x10(9)/L) | Standard Deviation 0.0215 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Lymphocytes | -0.064 (x10(9)/L) | Standard Deviation 0.4004 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Neutrophils | -0.094 (x10(9)/L) | Standard Deviation 1.238 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Eosinophils | -0.009 (x10(9)/L) | Standard Deviation 0.1072 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Tests | Platelet Count | -5.6 (x10(9)/L) | Standard Deviation 30.53 |
| Placebo | Assessment of Hematology Tests | Neutrophils | 0.083 (x10(9)/L) | Standard Deviation 0.7953 |
| Placebo | Assessment of Hematology Tests | Basophils | -0.005 (x10(9)/L) | Standard Deviation 0.0186 |
| Placebo | Assessment of Hematology Tests | Platelet Count | -4.5 (x10(9)/L) | Standard Deviation 31.56 |
| Placebo | Assessment of Hematology Tests | Eosinophils | 0.002 (x10(9)/L) | Standard Deviation 0.1168 |
| Placebo | Assessment of Hematology Tests | Monocytes | 0.009 (x10(9)/L) | Standard Deviation 0.1362 |
| Placebo | Assessment of Hematology Tests | Lymphocytes | 0.116 (x10(9)/L) | Standard Deviation 0.4972 |
| Placebo | Assessment of Hematology Tests | Leukocytes (WBC) | 0.207 (x10(9)/L) | Standard Deviation 1.0489 |
Primary
Assessment of Hematology Test Values
Change from baseline
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Basophils | 0.003 (x10(9)/L) | Standard Deviation 0.0181 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Neutrophils | 0.194 (x10(9)/L) | Standard Deviation 1.7491 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Monocytes | -0.024 (x10(9)/L) | Standard Deviation 0.1065 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Leukocytes (WBC) | 0.061 (x10(9)/L) | Standard Deviation 1.748 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Platelet Count | -11.2 (x10(9)/L) | Standard Deviation 34.86 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Eosinophils | -0.003 (x10(9)/L) | Standard Deviation 0.1029 |
| Ospemifene 30 mg (Dose 1) | Assessment of Hematology Test Values | Lymphocytes | -0.120 (x10(9)/L) | Standard Deviation 0.4796 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Monocytes | -0.028 (x10(9)/L) | Standard Deviation 0.1017 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Leukocytes (WBC) | -0.217 (x10(9)/L) | Standard Deviation 0.9597 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Basophils | 0.002 (x10(9)/L) | Standard Deviation 0.0281 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Lymphocytes | 0.001 (x10(9)/L) | Standard Deviation 0.3339 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Neutrophils | -0.258 (x10(9)/L) | Standard Deviation 0.9189 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Eosinophils | -0.005 (x10(9)/L) | Standard Deviation 0.0823 |
| Ospemifene 60 mg (Dose 2) | Assessment of Hematology Test Values | Platelet Count | -16.4 (x10(9)/L) | Standard Deviation 27.8 |
| Placebo | Assessment of Hematology Test Values | Neutrophils | 0.377 (x10(9)/L) | Standard Deviation 1.3568 |
| Placebo | Assessment of Hematology Test Values | Basophils | -0.003 (x10(9)/L) | Standard Deviation 0.0214 |
| Placebo | Assessment of Hematology Test Values | Platelet Count | -11.3 (x10(9)/L) | Standard Deviation 37.75 |
| Placebo | Assessment of Hematology Test Values | Eosinophils | 0.021 (x10(9)/L) | Standard Deviation 0.1889 |
| Placebo | Assessment of Hematology Test Values | Monocytes | 0.021 (x10(9)/L) | Standard Deviation 0.1216 |
| Placebo | Assessment of Hematology Test Values | Lymphocytes | -0.028 (x10(9)/L) | Standard Deviation 0.3352 |
| Placebo | Assessment of Hematology Test Values | Leukocytes (WBC) | 0.371 (x10(9)/L) | Standard Deviation 1.368 |
Primary
Assessment of Mammography
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Time frame: Week 52 (Visit 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Assessment of Mammography | Breast cyst | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Mammography | Breast mass | 2 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Mammography | Breast microcalcification | 0 Participants |
| Ospemifene 30 mg (Dose 1) | Assessment of Mammography | Mammogram abnormal | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Mammography | Mammogram abnormal | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Mammography | Breast cyst | 0 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Mammography | Breast microcalcification | 1 Participants |
| Ospemifene 60 mg (Dose 2) | Assessment of Mammography | Breast mass | 1 Participants |
| Placebo | Assessment of Mammography | Mammogram abnormal | 0 Participants |
| Placebo | Assessment of Mammography | Breast mass | 0 Participants |
| Placebo | Assessment of Mammography | Breast microcalcification | 0 Participants |
| Placebo | Assessment of Mammography | Breast cyst | 1 Participants |
Primary
Change From Baseline in Antithrombin Antigen, P Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Antithrombin Antigen, P Levels | 0.7 percent change | Standard Deviation 10.15 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Antithrombin Antigen, P Levels | -2.4 percent change | Standard Deviation 11.23 |
| Placebo | Change From Baseline in Antithrombin Antigen, P Levels | 1.2 percent change | Standard Deviation 10.49 |
Primary
Change From Baseline in Antithrombin Antigen, P Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Antithrombin Antigen, P Levels | 5.1 percent change | Standard Deviation 9.56 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Antithrombin Antigen, P Levels | 1.0 percent change | Standard Deviation 9.28 |
| Placebo | Change From Baseline in Antithrombin Antigen, P Levels | 7.1 percent change | Standard Deviation 11.64 |
Primary
Change From Baseline in BMI
Time frame: Baseline to Week 26
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in BMI | -0.331 kg/m^2 | Standard Deviation 1.4659 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in BMI | 0.253 kg/m^2 | Standard Deviation 1.1244 |
| Placebo | Change From Baseline in BMI | 0.293 kg/m^2 | Standard Deviation 1.0131 |
Primary
Change From Baseline in BMI
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in BMI | -0.379 kg/m^2 | Standard Deviation 1.8594 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in BMI | 0.376 kg/m^2 | Standard Deviation 1.1942 |
| Placebo | Change From Baseline in BMI | 0.748 kg/m^2 | Standard Deviation 1.1672 |
Primary
Change From Baseline in DBP
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in DBP | -2.5 mmHg | Standard Deviation 10.32 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in DBP | 0.7 mmHg | Standard Deviation 9.97 |
| Placebo | Change From Baseline in DBP | 0.8 mmHg | Standard Deviation 7.85 |
Primary
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Diastolic Blood Pressure (DBP) | -2.0 mmHg | Standard Deviation 9.49 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Diastolic Blood Pressure (DBP) | 0.5 mmHg | Standard Deviation 8.29 |
| Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) | 0.3 mmHg | Standard Deviation 8.07 |
Primary
Change From Baseline in E2 Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in E2 Levels | 0.06 pg/mL | Standard Deviation 1.27 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in E2 Levels | -0.02 pg/mL | Standard Deviation 1.05 |
| Placebo | Change From Baseline in E2 Levels | 0.14 pg/mL | Standard Deviation 0.69 |
Primary
Change From Baseline in Erythrocyte (RBC) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Erythrocyte (RBC) Levels | -0.081 (x10(12)/L) | Standard Deviation 0.2232 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Erythrocyte (RBC) Levels | -0.089 (x10(12)/L) | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Erythrocyte (RBC) Levels | 0.026 (x10(12)/L) | Standard Deviation 0.224 |
Primary
Change From Baseline in Erythrocyte (RBC) Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Erythrocyte (RBC) Levels | -0.087 (x10(12)/L) | Standard Deviation 0.2115 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Erythrocyte (RBC) Levels | -0.155 (x10(12)/L) | Standard Deviation 0.2113 |
| Placebo | Change From Baseline in Erythrocyte (RBC) Levels | 0.028 (x10(12)/L) | Standard Deviation 0.235 |
Primary
Change From Baseline in Estradiol (E2) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Estradiol (E2) Levels | 0.75 pg/mL | Standard Deviation 3.27 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Estradiol (E2) Levels | 0.94 pg/mL | Standard Deviation 5.97 |
| Placebo | Change From Baseline in Estradiol (E2) Levels | 0.15 pg/mL | Standard Deviation 0.79 |
Primary
Change From Baseline in Fibrinogen Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Fibrinogen Levels | -24.0 mg/dL | Standard Deviation 61.79 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Fibrinogen Levels | -36.0 mg/dL | Standard Deviation 67.82 |
| Placebo | Change From Baseline in Fibrinogen Levels | 7.4 mg/dL | Standard Deviation 96.67 |
Primary
Change From Baseline in Fibrinogen Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Fibrinogen Levels | -29.1 mg/dL | Standard Deviation 83.18 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Fibrinogen Levels | -25.9 mg/dL | Standard Deviation 63.17 |
| Placebo | Change From Baseline in Fibrinogen Levels | 12.1 mg/dL | Standard Deviation 70.52 |
Primary
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Follicle Stimulating Hormone (FSH) Levels | -7.44 IU/L | Standard Deviation 11.78 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Follicle Stimulating Hormone (FSH) Levels | -9.87 IU/L | Standard Deviation 14 |
| Placebo | Change From Baseline in Follicle Stimulating Hormone (FSH) Levels | -4.10 IU/L | Standard Deviation 11.37 |
Primary
Change From Baseline in FSH Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in FSH Levels | -12.39 IU/L | Standard Deviation 16.88 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in FSH Levels | -15.60 IU/L | Standard Deviation 13.32 |
| Placebo | Change From Baseline in FSH Levels | -6.29 IU/L | Standard Deviation 17.39 |
Primary
Change From Baseline in Hematocrit Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Hematocrit Levels | -0.445 percent change | Standard Deviation 1.9207 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Hematocrit Levels | -1.152 percent change | Standard Deviation 1.9113 |
| Placebo | Change From Baseline in Hematocrit Levels | 0.174 percent change | Standard Deviation 2.0823 |
Primary
Change From Baseline in Hematocrit Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Hematocrit Levels | -0.435 percent change | Standard Deviation 2.0189 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Hematocrit Levels | -0.529 percent change | Standard Deviation 2.1667 |
| Placebo | Change From Baseline in Hematocrit Levels | 0.398 percent change | Standard Deviation 1.9951 |
Primary
Change From Baseline in Hemoglobin Levels
Time frame: Baseine to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Hemoglobin Levels | -0.141 g/dL | Standard Deviation 0.6261 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Hemoglobin Levels | -0.431 g/dL | Standard Deviation 0.6367 |
| Placebo | Change From Baseline in Hemoglobin Levels | 0.094 g/dL | Standard Deviation 0.6121 |
Primary
Change From Baseline in Hemogobin Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Hemogobin Levels | -0.150 g/dL | Standard Deviation 0.6664 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Hemogobin Levels | -0.165 g/dL | Standard Deviation 0.6668 |
| Placebo | Change From Baseline in Hemogobin Levels | 0.140 g/dL | Standard Deviation 0.6247 |
Primary
Change From Baseline in LH Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in LH Levels | -2.65 IU/L | Standard Deviation 6.73 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in LH Levels | -4.95 IU/L | Standard Deviation 7.59 |
| Placebo | Change From Baseline in LH Levels | -0.09 IU/L | Standard Deviation 5.45 |
Primary
Change From Baseline in Luteinizing Hormone (LH) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Luteinizing Hormone (LH) Levels | -2.02 IU/L | Standard Deviation 5.26 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Luteinizing Hormone (LH) Levels | -2.86 IU/L | Standard Deviation 6.97 |
| Placebo | Change From Baseline in Luteinizing Hormone (LH) Levels | -0.83 IU/L | Standard Deviation 4.82 |
Primary
Change From Baseline in pH of Urine
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in pH of Urine | 0.2 pH | Standard Deviation 1.28 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in pH of Urine | 0.0 pH | Standard Deviation 0.97 |
| Placebo | Change From Baseline in pH of Urine | 0.1 pH | Standard Deviation 1.15 |
Primary
Change From Baseline in pH of Urine
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in pH of Urine | 0.1 pH | Standard Deviation 1.17 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in pH of Urine | 0.0 pH | Standard Deviation 1.15 |
| Placebo | Change From Baseline in pH of Urine | 0.2 pH | Standard Deviation 1.2 |
Primary
Change From Baseline in Protein C Ag, P Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Protein C Ag, P Levels | 8.2 percent change | Standard Deviation 20.2 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Protein C Ag, P Levels | -2.0 percent change | Standard Deviation 20.68 |
| Placebo | Change From Baseline in Protein C Ag, P Levels | 14.2 percent change | Standard Deviation 21.96 |
Primary
Change From Baseline in Protein C Ag, P Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Protein C Ag, P Levels | 4.9 percent change | Standard Deviation 17.11 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Protein C Ag, P Levels | -2.9 percent change | Standard Deviation 19.2 |
| Placebo | Change From Baseline in Protein C Ag, P Levels | 10.6 percent change | Standard Deviation 20.11 |
Primary
Change From Baseline in Protein S Ag (Free), P Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Protein S Ag (Free), P Levels | 4.7 percent change | Standard Deviation 13.33 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Protein S Ag (Free), P Levels | 6.8 percent change | Standard Deviation 12.82 |
| Placebo | Change From Baseline in Protein S Ag (Free), P Levels | 4.8 percent change | Standard Deviation 9.79 |
Primary
Change From Baseline in Protein S Ag (Free), P Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Protein S Ag (Free), P Levels | 7.1 percent change | Standard Deviation 16.77 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Protein S Ag (Free), P Levels | 11.1 percent change | Standard Deviation 13.78 |
| Placebo | Change From Baseline in Protein S Ag (Free), P Levels | 9.3 percent change | Standard Deviation 15.92 |
Primary
Change From Baseline in Pulse Rate
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Pulse Rate | 2.6 bpm | Standard Deviation 9.78 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Pulse Rate | -0.5 bpm | Standard Deviation 12.05 |
| Placebo | Change From Baseline in Pulse Rate | 2.9 bpm | Standard Deviation 6.61 |
Primary
Change From Baseline in Pulse Rate
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Pulse Rate | 2.0 bpm | Standard Deviation 11.71 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Pulse Rate | 0.8 bpm | Standard Deviation 10.61 |
| Placebo | Change From Baseline in Pulse Rate | 2.2 bpm | Standard Deviation 8.6 |
Primary
Change From Baseline in SBP
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in SBP | -4.5 mmHg | Standard Deviation 15.28 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in SBP | 0.9 mmHg | Standard Deviation 15.3 |
| Placebo | Change From Baseline in SBP | 4.2 mmHg | Standard Deviation 15.21 |
Primary
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels | 11.71 nmol/L | Standard Deviation 19.64 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels | 22.64 nmol/L | Standard Deviation 28.07 |
| Placebo | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels | -2.74 nmol/L | Standard Deviation 12.84 |
Primary
Change From Baseline in SHBG Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in SHBG Levels | 11.94 nmol/L | Standard Deviation 20.81 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in SHBG Levels | 28.09 nmol/L | Standard Deviation 25.62 |
| Placebo | Change From Baseline in SHBG Levels | -5.94 nmol/L | Standard Deviation 13.33 |
Primary
Change From Baseline in Specific Gravity of Urine
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Specific Gravity of Urine | -0.001 units | Standard Deviation 0.0061 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Specific Gravity of Urine | -0.002 units | Standard Deviation 0.0074 |
| Placebo | Change From Baseline in Specific Gravity of Urine | -0.001 units | Standard Deviation 0.0067 |
Primary
Change From Baseline in Specific Gravtiy of Urine
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Specific Gravtiy of Urine | -0.002 units | Standard Deviation 0.0074 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Specific Gravtiy of Urine | -0.003 units | Standard Deviation 0.0062 |
| Placebo | Change From Baseline in Specific Gravtiy of Urine | -0.000 units | Standard Deviation 0.0065 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Systolic Blood Pressure (SBP) | -2.1 mmHg | Standard Deviation 15.33 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Systolic Blood Pressure (SBP) | 2.4 mmHg | Standard Deviation 12.16 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) | 0.5 mmHg | Standard Deviation 11.16 |
Primary
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Testosterone (Free) Levels | 0.02 ng/dL | Standard Deviation 0.1 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Testosterone (Free) Levels | -0.01 ng/dL | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Testosterone (Free) Levels | 0.01 ng/dL | Standard Deviation 0.12 |
Primary
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Testosterone (Free) Levels | -0.01 ng/dL | Standard Deviation 0.13 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Testosterone (Free) Levels | -0.00 ng/dL | Standard Deviation 0.22 |
| Placebo | Change From Baseline in Testosterone (Free) Levels | -0.03 ng/dL | Standard Deviation 0.15 |
Primary
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Testosterone (Total) Levels | 1.61 ng/dL | Standard Deviation 5.29 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Testosterone (Total) Levels | 2.59 ng/dL | Standard Deviation 5.75 |
| Placebo | Change From Baseline in Testosterone (Total) Levels | -0.76 ng/dL | Standard Deviation 7.18 |
Primary
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Testosterone (Total) Levels | 1.92 ng/dL | Standard Deviation 5.13 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Testosterone (Total) Levels | 3.48 ng/dL | Standard Deviation 7.86 |
| Placebo | Change From Baseline in Testosterone (Total) Levels | -0.95 ng/dL | Standard Deviation 4.6 |
Primary
Change From Baseline in Thromboplastin Time
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Thromboplastin Time | 0.5 s | Standard Deviation 7.48 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Thromboplastin Time | -0.6 s | Standard Deviation 3.37 |
| Placebo | Change From Baseline in Thromboplastin Time | 0.3 s | Standard Deviation 2.87 |
Primary
Change From Baseline in Thromboplastin Time
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Thromboplastin Time | 0.4 s | Standard Deviation 4.13 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Thromboplastin Time | 0.5 s | Standard Deviation 3.43 |
| Placebo | Change From Baseline in Thromboplastin Time | 1.2 s | Standard Deviation 5.05 |
Primary
Change From Baseline in Visual Evaluation of the Vagina
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -1.6 Units on a scale | Standard Deviation 1.07 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.9 Units on a scale | Standard Deviation 1.02 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.7 Units on a scale | Standard Deviation 0.94 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -1.3 Units on a scale | Standard Deviation 0.89 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.8 Units on a scale | Standard Deviation 0.96 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.8 Units on a scale | Standard Deviation 0.95 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.6 Units on a scale | Standard Deviation 0.82 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -1.2 Units on a scale | Standard Deviation 1.02 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -1.4 Units on a scale | Standard Deviation 0.91 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.7 Units on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.4 Units on a scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -0.8 Units on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.3 Units on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.6 Units on a scale | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -0.5 Units on a scale | Standard Deviation 0.94 |
Primary
Change From Baseline in Visual Evaluation of the Vagina
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -1.7 Units on a scale | Standard Deviation 0.96 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.9 Units on a scale | Standard Deviation 0.91 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.8 Units on a scale | Standard Deviation 0.85 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -1.3 Units on a scale | Standard Deviation 0.74 |
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.8 Units on a scale | Standard Deviation 0.96 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.7 Units on a scale | Standard Deviation 0.95 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.7 Units on a scale | Standard Deviation 0.91 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -1.2 Units on a scale | Standard Deviation 1.15 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -1.4 Units on a scale | Standard Deviation 1.06 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.6 Units on a scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Redness in Mucosa | -0.5 Units on a scale | Standard Deviation 1.07 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Vaginal Dryness in Mucosa | -1.1 Units on a scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.4 Units on a scale | Standard Deviation 0.73 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.5 Units on a scale | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -0.6 Units on a scale | Standard Deviation 1.03 |
Primary
Change From Baseline in Weight
Time frame: Baseline to Week 26 (Visit 5)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Weight | -0.88 kg | Standard Deviation 3.902 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Weight | 0.66 kg | Standard Deviation 2.997 |
| Placebo | Change From Baseline in Weight | 0.78 kg | Standard Deviation 2.732 |
Primary
Change From Baseline in Weight
Time frame: Baseline to Week 52 (Visit 6)
Population: The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Change From Baseline in Weight | -0.99 kg | Standard Deviation 4.975 |
| Ospemifene 60 mg (Dose 2) | Change From Baseline in Weight | 0.98 kg | Standard Deviation 3.055 |
| Placebo | Change From Baseline in Weight | 1.99 kg | Standard Deviation 3.084 |
Primary
Incidence of Adverse Events (AEs)
Time frame: Week 20 (Phone Contact) to Week 56 (Visit 7)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Incidence of Adverse Events (AEs) | Serious AE | 2 Participants |
| Ospemifene 30 mg (Dose 1) | Incidence of Adverse Events (AEs) | AE Causing Study Drug Discontinuation | 3 Participants |
| Ospemifene 30 mg (Dose 1) | Incidence of Adverse Events (AEs) | Treatment-Emergent AE | 38 Participants |
| Ospemifene 30 mg (Dose 1) | Incidence of Adverse Events (AEs) | Related AE (Possibly/Probably/Definitely Related) | 11 Participants |
| Ospemifene 30 mg (Dose 1) | Incidence of Adverse Events (AEs) | Severe AE | 6 Participants |
| Ospemifene 60 mg (Dose 2) | Incidence of Adverse Events (AEs) | AE Causing Study Drug Discontinuation | 4 Participants |
| Ospemifene 60 mg (Dose 2) | Incidence of Adverse Events (AEs) | Treatment-Emergent AE | 44 Participants |
| Ospemifene 60 mg (Dose 2) | Incidence of Adverse Events (AEs) | Related AE (Possibly/Probably/Definitely Related) | 18 Participants |
| Ospemifene 60 mg (Dose 2) | Incidence of Adverse Events (AEs) | Serious AE | 5 Participants |
| Ospemifene 60 mg (Dose 2) | Incidence of Adverse Events (AEs) | Severe AE | 7 Participants |
| Placebo | Incidence of Adverse Events (AEs) | Severe AE | 2 Participants |
| Placebo | Incidence of Adverse Events (AEs) | Serious AE | 1 Participants |
| Placebo | Incidence of Adverse Events (AEs) | Treatment-Emergent AE | 22 Participants |
| Placebo | Incidence of Adverse Events (AEs) | AE Causing Study Drug Discontinuation | 1 Participants |
| Placebo | Incidence of Adverse Events (AEs) | Related AE (Possibly/Probably/Definitely Related) | 5 Participants |
Primary
Mean Change in Blood Chemistry Parameters
Time frame: Baseline to Week 26 (Visit 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | Aspartate Aminotransferase (AST) | 0.8 U/L | Standard Deviation 4.67 |
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | Alanine Aminotransferase (ALT) | -1.2 U/L | Standard Deviation 9.39 |
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | Creatine Kinase (CK) | 1.1 U/L | Standard Deviation 50.97 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | Aspartate Aminotransferase (AST) | 1.2 U/L | Standard Deviation 5.43 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | Alanine Aminotransferase (ALT) | -1.3 U/L | Standard Deviation 8.73 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | Creatine Kinase (CK) | -4.4 U/L | Standard Deviation 48.78 |
| Placebo | Mean Change in Blood Chemistry Parameters | Alanine Aminotransferase (ALT) | -1.3 U/L | Standard Deviation 8.22 |
| Placebo | Mean Change in Blood Chemistry Parameters | Creatine Kinase (CK) | 18.7 U/L | Standard Deviation 69.5 |
| Placebo | Mean Change in Blood Chemistry Parameters | Aspartate Aminotransferase (AST) | 0.5 U/L | Standard Deviation 4.59 |
Primary
Mean Change in Blood Chemistry Parameters
Time frame: Baseline to Week 52 (Visit 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | AST | 1.5 U/L | Standard Deviation 4.99 |
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | ALT | -2.1 U/L | Standard Deviation 10.27 |
| Ospemifene 30 mg (Dose 1) | Mean Change in Blood Chemistry Parameters | CK | 7.3 U/L | Standard Deviation 62.7 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | AST | 0.5 U/L | Standard Deviation 5.03 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | ALT | -3.2 U/L | Standard Deviation 7.91 |
| Ospemifene 60 mg (Dose 2) | Mean Change in Blood Chemistry Parameters | CK | 1.2 U/L | Standard Deviation 56.78 |
| Placebo | Mean Change in Blood Chemistry Parameters | ALT | -2.2 U/L | Standard Deviation 7.21 |
| Placebo | Mean Change in Blood Chemistry Parameters | CK | -6.0 U/L | Standard Deviation 31.82 |
| Placebo | Mean Change in Blood Chemistry Parameters | AST | 0.3 U/L | Standard Deviation 4.95 |
Primary
Mean Percent Change From Baseline in Serum Lipids
Time frame: Baseline to Week 26 (Visit 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | -0.14 percent change | Standard Deviation 14.807 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | Low-density-lipoprotein cholesterol (LDL-C) | -0.02 percent change | Standard Deviation 19.462 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | High-density-lipoprotein cholesterol (HDL-C) | 6.48 percent change | Standard Deviation 13.881 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | -0.66 percent change | Standard Deviation 28.864 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | 5.12 percent change | Standard Deviation 31.076 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | 2.35 percent change | Standard Deviation 13.663 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | High-density-lipoprotein cholesterol (HDL-C) | 5.76 percent change | Standard Deviation 12.686 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | Low-density-lipoprotein cholesterol (LDL-C) | 2.42 percent change | Standard Deviation 19.107 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | 20.36 percent change | Standard Deviation 41.755 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | Low-density-lipoprotein cholesterol (LDL-C) | 10.38 percent change | Standard Deviation 19.776 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | High-density-lipoprotein cholesterol (HDL-C) | 2.39 percent change | Standard Deviation 14.026 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | 6.24 percent change | Standard Deviation 12.904 |
Primary
Mean Percent Change From Baseline in Serum Lipids
Time frame: Baseline to Week 52 (Visit 6)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | -0.55 percent change | Standard Deviation 13.91 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | LDL-C | -0.87 percent change | Standard Deviation 19.748 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | HDL-C | 6.07 percent change | Standard Deviation 16.836 |
| Ospemifene 30 mg (Dose 1) | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | -3.10 percent change | Standard Deviation 32.749 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | 15.19 percent change | Standard Deviation 35.789 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | -2.45 percent change | Standard Deviation 12.323 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | HDL-C | 1.29 percent change | Standard Deviation 12.787 |
| Ospemifene 60 mg (Dose 2) | Mean Percent Change From Baseline in Serum Lipids | LDL-C | -6.20 percent change | Standard Deviation 18.623 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | Triglycerides | 21.57 percent change | Standard Deviation 40.802 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | LDL-C | -0.42 percent change | Standard Deviation 15.418 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | HDL-C | -4.41 percent change | Standard Deviation 14.347 |
| Placebo | Mean Percent Change From Baseline in Serum Lipids | Total Cholesterol | -1.05 percent change | Standard Deviation 9.289 |