Atrophy, Vaginal Diseases
Conditions
Keywords
Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms, Vaginal atrophy, Urogenital atrophy
Brief summary
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
Interventions
DRUGOspemifene 60 mg
60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
DRUGPlacebo
oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Sponsors
Hormos Medical
QuatRx Pharmaceuticals
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Naturally or surgically menopausal * Moderate or severe symptoms of vaginal atrophy * 5% or fewer superficial cells in maturation index of vaginal smear * Vaginal pH greater than 5.0 * Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization
Exclusion criteria
* Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids * Current vaginal infection requiring medication * Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g. uterine or vaginal prolapse of Grade 2 or higher) * Previous participation in any other ospemifene study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 12 weeks |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | 12 weeks |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 12 weeks |
| Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | 12 weeks |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 12 weeks |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | 12 weeks |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 12 weeks |
| Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 4 weeks |
| Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) | 4 weeks |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) | 4 weeks |
Participant flow
Recruitment details
First patient was screened on August 04, 2008 and last patient completed on July 30, 2009
Pre-assignment details
Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS
Participants by arm
| Arm | Count |
|---|---|
| Subjects on Placebo Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. | 456 |
| Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. | 463 |
| Total | 919 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 25 |
| Overall Study | Lost to Follow-up | 9 | 9 |
| Overall Study | Other-Not mentioned | 9 | 4 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 19 | 8 |
Baseline characteristics
| Characteristic | Subjects on Placebo | Subjects on Ospemifene 60 mg/Day | Total |
|---|---|---|---|
| Age, Continuous | 58.5 Years STANDARD_DEVIATION 6.39 | 58.7 Years STANDARD_DEVIATION 6.56 | 58.6 Years STANDARD_DEVIATION 6.47 |
| Age, Customized <45 | 7 participants | 8 participants | 15 participants |
| Age, Customized 45-54 | 106 participants | 113 participants | 219 participants |
| Age, Customized 55-64 | 266 participants | 260 participants | 526 participants |
| Age, Customized >=65 | 77 participants | 82 participants | 159 participants |
| BMI | 26.21 kg/m^2 STANDARD_DEVIATION 4.32 | 26.16 kg/m^2 STANDARD_DEVIATION 4.31 | 26.18 kg/m^2 STANDARD_DEVIATION 4.31 |
| Height | 162.6 cm STANDARD_DEVIATION 6.39 | 162.3 cm STANDARD_DEVIATION 6.34 | 162.5 cm STANDARD_DEVIATION 6.36 |
| Race/Ethnicity, Customized Asian | 3 participants | 8 participants | 11 participants |
| Race/Ethnicity, Customized Black or African American | 35 participants | 28 participants | 63 participants |
| Race/Ethnicity, Customized Other | 22 participants | 16 participants | 38 participants |
| Race/Ethnicity, Customized Pacific Islander | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 396 participants | 409 participants | 805 participants |
| Sex: Female, Male Female | 456 Participants | 463 Participants | 919 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 69.38 kg STANDARD_DEVIATION 12.38 | 68.98 kg STANDARD_DEVIATION 12.38 | 69.18 kg STANDARD_DEVIATION 12.37 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 102 / 456 | 153 / 463 |
| serious Total, serious adverse events | 7 / 456 | 6 / 463 |
Outcome results
Primary
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | -3.7 percentage of parabasal cells | Standard Deviation 29.97 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | -31.7 percentage of parabasal cells | Standard Deviation 37.25 |
Primary
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | 0.0 percentage of parabasal cells | Standard Deviation 30 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | -40.2 percentage of parabasal cells | Standard Deviation 38.8 |
Primary
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 3.3 percentage of superficial cells | Standard Deviation 9.02 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 12.4 percentage of superficial cells | Standard Deviation 15.36 |
Primary
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 1.7 percentage of superficial cells | Standard Deviation 6.88 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 12.3 percentage of superficial cells | Standard Deviation 14.77 |
Primary
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -2 (Sev. to mild, or mod. to none) | 39 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 0 (No change) | 44 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -1 (Sev. to mod., mod.to mild, or mild to none) | 52 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 1 (None to mild, mild to mod., or mod. to sev.) | 5 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -3 (Sev. to none) | 14 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 1 (None to mild, mild to mod., or mod. to sev.) | 3 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -3 (Sev. to none) | 23 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -2 (Sev. to mild, or mod. to none) | 51 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -1 (Sev. to mod., mod.to mild, or mild to none) | 39 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 0 (No change) | 44 participants |
Primary
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -2 (Sev. to mild, or mod. to none) | 70 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 0 (No change) | 102 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -1 (Sev. to mod., mod.to mild, or mild to none) | 76 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 1 (None to mild, mild to mod., or mod. to sev.) | 7 participants |
| Subjects on Placebo | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -3 (Sev. to none) | 47 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 1 (None to mild, mild to mod., or mod. to sev.) | 6 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -3 (Sev. to none) | 67 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -2 (Sev. to mild, or mod. to none) | 93 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -1 (Sev. to mod., mod.to mild, or mild to none) | 82 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 0 (No change) | 55 participants |
Primary
Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | -0.24 pH | Standard Deviation 0.8 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | -0.92 pH | Standard Deviation 1.1 |
Primary
Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)
Time frame: 12 weeks
Population: ITT; LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | -0.07 pH | Standard Deviation 0.814 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | -0.94 pH | Standard Deviation 1.016 |
Secondary
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | -2.8 percentage of parabasal cells | Standard Deviation 2.18 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | -31.2 percentage of parabasal cells | Standard Deviation 2.15 |
Secondary
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) | -0.8 percentage of parabasal cells | Standard Deviation 1.59 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) | -37.8 percentage of parabasal cells | Standard Deviation 1.54 |
Secondary
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 3.6 percentage of superficial cells | Standard Deviation 1.07 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 12.7 percentage of superficial cells | Standard Deviation 1.05 |
Secondary
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) | 1.9 percentage of superficial cells | Standard Deviation 0.69 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) | 13.0 percentage of superficial cells | Standard Deviation 0.67 |
Secondary
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)
Time frame: 4 weeks
Population: ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -2 (Sev. to Mild, or Mod. to None) | 25 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 0 (No change) | 60 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -1 (Sev. to Mod., Mod. to Mild, or Mild to None) | 57 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 1 (None to Mild, Mild to Mod., or Mod. to Sev.) | 1 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -3 (Sev. to None) | 9 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 1 (None to Mild, Mild to Mod., or Mod. to Sev.) | 5 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -3 (Sev. to None) | 11 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -2 (Sev. to Mild, or Mod. to None) | 31 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | -1 (Sev. to Mod., Mod. to Mild, or Mild to None) | 67 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 0 (No change) | 40 participants |
Secondary
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)
Time frame: 4 weeks
Population: ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -2 (Sev. to Mild, or Mod. to None) | 64 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 0 (No change) | 95 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -1 (Sev. to Mod., Mod. to Mild, or Mild to None) | 84 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 1 (None to Mild, Mild to Mod., or Mod. to Sev.) | 10 participants |
| Subjects on Placebo | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -3 (Sev. to None) | 34 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 1 (None to Mild, Mild to Mod., or Mod. to Sev.) | 9 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -3 (Sev. to None) | 39 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -2 (Sev. to Mild, or Mod. to None) | 72 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | -1 (Sev. to Mod., Mod. to Mild, or Mild to None) | 97 participants |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 0 (No change) | 78 participants |
Secondary
Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) | -0.21 pH | Standard Deviation 0.884 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) | -0.81 pH | Standard Deviation 0.962 |
Secondary
Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)
Time frame: 4 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects on Placebo | Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) | -0.15 pH | Standard Deviation 0.821 |
| Subjects on Ospemifene 60 mg/Day | Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) | -0.82 pH | Standard Deviation 0.979 |