Atrophy, Vaginal Diseases
Conditions
Keywords
Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in postmenopausal women, Vaginal atrophy
Brief summary
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.
Interventions
DRUGPlacebo
1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
DRUGOspemifene 5 mg
1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
DRUGOspemifene 15 mg
1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
DRUGOspemifene 30 mg
1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Sponsors
Hormos Medical
QuatRx Pharmaceuticals
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Naturally or surgically menopausal * Vaginal pH greater than 5.0 * 5% or fewer superficial cells in maturation index of vaginal smear
Exclusion criteria
* Evidence of endometrial hyperplasia, cancer or other pathology * Abnormal PAP smear * Uterine bleeding of unknown origin or uterine polyps * Current vaginal infection requiring medication * Use of hormonal medications * Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 12 weeks |
| Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 12 weeks |
| Mean Change From Baseline in Vaginal pH | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in Estradiol Levels | Week 12 |
| Mean Change From Baseline in Luteinizing Hormone Levels | Week 12 |
| Visual Evaluation of Vagina (by Gynecological Examination) | Screening & Week 12 |
| Mean Change From Baseline in Sex Hormone Binding Globulin Levels | Week 12 |
| Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | Week 4 |
| Mean Change From Baseline in Follicle Stimulating Hormone Levels | Week 12 |
| Mean Change From Baseline in Vaginal pH | Week 4 |
| Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | Week 4 |
Participant flow
Recruitment details
The study was conducted at 9 centers in Finland. First patient was enrolled on August 09, 2007 and last patient completed on February 11, 2008
Pre-assignment details
The study population included postmenopausal women 40 to 80 years of age with a diagnosis of vulvar and vaginal atrophy (VVA) assessed by the maturation index (MI) of vaginal smear and vaginal pH at baseline
Participants by arm
| Arm | Count |
|---|---|
| Subjects on Placebo Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks | 34 |
| Subjects on Ospemifene 5 mg/Day Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks | 33 |
| Subjects on Ospemifene 15 mg/Day Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks | 29 |
| Subjects on Ospemifene 30 mg/Day Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks | 30 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Subjects on Placebo | Subjects on Ospemifene 5 mg/Day | Subjects on Ospemifene 15 mg/Day | Subjects on Ospemifene 30 mg/Day | Total |
|---|---|---|---|---|---|
| Age Continuous | 62.8 years STANDARD_DEVIATION 6 | 61.5 years STANDARD_DEVIATION 5.6 | 63.4 years STANDARD_DEVIATION 7.1 | 62.0 years STANDARD_DEVIATION 6.8 | 62.4 years STANDARD_DEVIATION 6.4 |
| Alcohol | 0.9 drinks/week STANDARD_DEVIATION 1.9 | 1.8 drinks/week STANDARD_DEVIATION 2.4 | 1.2 drinks/week STANDARD_DEVIATION 1.7 | 1.5 drinks/week STANDARD_DEVIATION 2.3 | 1.4 drinks/week STANDARD_DEVIATION 2.1 |
| BMI | 26.89 kg/m^2 STANDARD_DEVIATION 3.95 | 24.78 kg/m^2 STANDARD_DEVIATION 3.44 | 25.50 kg/m^2 STANDARD_DEVIATION 4.99 | 25.28 kg/m^2 STANDARD_DEVIATION 3.2 | 25.61 kg/m^2 STANDARD_DEVIATION 3.9 |
| Height | 1.609 m STANDARD_DEVIATION 0.049 | 1.636 m STANDARD_DEVIATION 0.051 | 1.641 m STANDARD_DEVIATION 0.062 | 1.617 m STANDARD_DEVIATION 0.058 | 1.626 m STANDARD_DEVIATION 0.055 |
| Race/Ethnicity, Customized Participants | 34 participants | 33 participants | 29 participants | 30 participants | 126 participants |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 29 Participants | 30 Participants | 126 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 69.6 kg STANDARD_DEVIATION 10.1 | 66.5 kg STANDARD_DEVIATION 10.6 | 68.7 kg STANDARD_DEVIATION 13.5 | 65.9 kg STANDARD_DEVIATION 7.4 | 67.7 kg STANDARD_DEVIATION 10.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 34 | 7 / 33 | 13 / 29 | 16 / 30 |
| serious Total, serious adverse events | 1 / 34 | 0 / 33 | 0 / 29 | 0 / 30 |
Outcome results
Primary
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | -3.0 percentage of parabasal cells | Standard Deviation 30.2 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | -2.8 percentage of parabasal cells | Standard Deviation 33.2 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | -24.1 percentage of parabasal cells | Standard Deviation 36.7 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | -26.8 percentage of parabasal cells | Standard Deviation 41.1 |
Primary
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 0.2 percentage of superficial cells | Standard Deviation 1.5 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 0.9 percentage of superficial cells | Standard Deviation 3.1 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 5.0 percentage of superficial cells | Standard Deviation 9.1 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 5.6 percentage of superficial cells | Standard Deviation 10.3 |
Primary
Mean Change From Baseline in Vaginal pH
Time frame: 12 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Vaginal pH | -0.07 pH | Standard Deviation 0.91 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Vaginal pH | -0.37 pH | Standard Deviation 0.83 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Vaginal pH | -0.95 pH | Standard Deviation 1.02 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Vaginal pH | -1.11 pH | Standard Deviation 1.06 |
Secondary
Mean Change From Baseline in Estradiol Levels
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Estradiol Levels | -0.004 nmol/L | Standard Deviation 0.011 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Estradiol Levels | 0.004 nmol/L | Standard Deviation 0.015 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Estradiol Levels | -0.010 nmol/L | Standard Deviation 0.026 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Estradiol Levels | -0.003 nmol/L | Standard Deviation 0.008 |
Secondary
Mean Change From Baseline in Follicle Stimulating Hormone Levels
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Follicle Stimulating Hormone Levels | -10.36 U/L | Standard Deviation 20.41 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Follicle Stimulating Hormone Levels | -7.04 U/L | Standard Deviation 10.8 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Follicle Stimulating Hormone Levels | -5.99 U/L | Standard Deviation 23.07 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Follicle Stimulating Hormone Levels | -15.32 U/L | Standard Deviation 13.13 |
Secondary
Mean Change From Baseline in Luteinizing Hormone Levels
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Luteinizing Hormone Levels | -1.36 U/L | Standard Deviation 4.71 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Luteinizing Hormone Levels | -2.89 U/L | Standard Deviation 5.94 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Luteinizing Hormone Levels | -0.34 U/L | Standard Deviation 9.23 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Luteinizing Hormone Levels | -3.78 U/L | Standard Deviation 7.34 |
Secondary
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index
Time frame: Week 4
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | -0.6 percentage of parabasal cells | Standard Deviation 24.1 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | -0.6 percentage of parabasal cells | Standard Deviation 23.8 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | -19.7 percentage of parabasal cells | Standard Deviation 27 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | -22.0 percentage of parabasal cells | Standard Deviation 42.7 |
Secondary
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index
Time frame: Week 4
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | 0.6 percentage of superficial cells | Standard Deviation 2.7 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | 0.6 percentage of superficial cells | Standard Deviation 2.9 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | 2.5 percentage of superficial cells | Standard Deviation 5.6 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | 5.0 percentage of superficial cells | Standard Deviation 10.7 |
Secondary
Mean Change From Baseline in Sex Hormone Binding Globulin Levels
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Sex Hormone Binding Globulin Levels | -2.4 nmol/L | Standard Deviation 10 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Sex Hormone Binding Globulin Levels | 2.9 nmol/L | Standard Deviation 12.2 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Sex Hormone Binding Globulin Levels | 6.3 nmol/L | Standard Deviation 12.5 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Sex Hormone Binding Globulin Levels | 18.0 nmol/L | Standard Deviation 20.2 |
Secondary
Mean Change From Baseline in Vaginal pH
Time frame: Week 4
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Mean Change From Baseline in Vaginal pH | -0.12 pH | Standard Deviation 0.59 |
| Subjects on Ospemifene 5 mg/Day | Mean Change From Baseline in Vaginal pH | -0.26 pH | Standard Deviation 0.68 |
| Subjects on Ospemifene 15 mg/Day | Mean Change From Baseline in Vaginal pH | -0.53 pH | Standard Deviation 0.83 |
| Subjects on Ospemifene 30 mg/Day | Mean Change From Baseline in Vaginal pH | -0.78 pH | Standard Deviation 1 |
Secondary
Visual Evaluation of Vagina (by Gynecological Examination)
Time frame: Screening & Week 12
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 8.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 41.2 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 47.1 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 5.9 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 26.5 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 14.7 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 11.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 26.5 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 52.9 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 11.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 8.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 5.9 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 38.2 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 47.1 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 8.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 8.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 11.8 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 44.1 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 38.2 percentage of subjects |
| Subjects on Placebo | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 41.2 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 2.9 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 35.3 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 29.4 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 2.9 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 23.5 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 5.9 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 11.8 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 32.4 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 26.5 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 20.6 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 41.2 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 26.5 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 41.2 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 41.2 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 32.4 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 14.7 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 8.8 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 35.3 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 20.6 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 47.1 percentage of subjects |
| Subjects on Ospemifene 5 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 6.1 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 24.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 12.1 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 21.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 6.1 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 30.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 57.6 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 6.1 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 15.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 27.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 36.4 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 21.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 21.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 63.6 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 9.1 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 18.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 33.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 33.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 15.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 42.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 36.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 6.1 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 27.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 30.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 15.2 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 36.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 21.2 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 39.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 30.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 33.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 39.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 15.2 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 21.2 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 15.2 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 30.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 48.5 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 3.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 30.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 31.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 17.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 48.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 31.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 3.4 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 48.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 10.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 10.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 6.9 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 13.8 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 31.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 10.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 6.9 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 48.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 41.4 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 55.2 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 37.9 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 34.5 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 10.3 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 3.4 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 15 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 24.1 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 3.4 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 27.6 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 44.8 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 3.4 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 6.9 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 6.9 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 10.3 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 17.2 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 55.2 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 3.4 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 3.4 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 17.2 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 51.7 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 48.3 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 51.7 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 37.9 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 44.8 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 37.9 percentage of subjects |
| Subjects on Ospemifine 15 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 3.4 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 43.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 40.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 16.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 40.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 23.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 6.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 20.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 10.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 43.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 33.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 10.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 13.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 10.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 10.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 26.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 50.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 23.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 16.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 53.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 10.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Mild | 30.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-None | 53.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Severe | 3.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Mild | 33.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Severe | 3.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-None | 60.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Moderate | 6.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Mild | 43.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Moderate | 6.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-Mild | 16.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-None | 60.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal dryness in the mucosa-None | 73.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Severe | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Moderate | 3.3 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Friability-Not done | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Mild | 40.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Pallor-None | 46.7 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Vaginal redness in the mucosa-Moderate | 0.0 percentage of subjects |
| Subjects on Ospemifene 30 mg/Day (Week 12) | Visual Evaluation of Vagina (by Gynecological Examination) | Petechiae-Moderate | 3.3 percentage of subjects |