Atrophy, Vaginal Diseases
Conditions
Keywords
Urogenital atrophy, Vaginal atrophy, Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms
Brief summary
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
Interventions
DRUGOspemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUGOspemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUGPlacebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUGNonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Sponsors
Hormos Medical
QuatRx Pharmaceuticals
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Naturally or surgically postmenopausal * Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse) * Vaginal pH greater than 5.0 * 5% or fewer superficial cells in maturation index of vaginal smear
Exclusion criteria
* Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology * Abnormal Pap smear * Uterine bleeding of unknown origin or uterine polyps * Current vaginal infection requiring medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | Baseline (Randomization) to Week 12 | This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe |
| Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | Baseline (Randomization) to Week 12 | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe |
| Mean Change From Baseline in Vaginal pH | Baseline (Screening) to Week 12 | — |
| Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | Baseline (Screening) to Week 12 | — |
| Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | Baseline (Screening) to Week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sex Hormone Binding Globulin Levels | Baseline (Screening) to Week 12 | — |
| Change From Baseline in Testosterone (Free) Levels | Baseline (Screening) to Week 12 | — |
| Change From Baseline in Visual Evaluation of the Vagina | Baseline (Screening) to Week 12 | Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe |
| Change From Baseline in Urinary Symptoms | Baseline (Randomization) to Week 12 | — |
| Change From Baseline in Testosterone (Total) Levels | Baseline (Screening) to Week 12 | — |
| Change From Baseline in Severity of VVA Symptoms | Baseline (Randomization) to Week 12 | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe |
| Change From Baseline in Estradiol Levels | Baseline (Screening) to Week 12 | — |
| Change From Baseline in Follicle Stimulating Hormone Levels | Baseline (Screening) to Week 12 | — |
| Change From Baseline in Luteinizing Hormone Levels | Baseline (Screening) to Week 12 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. | 282 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. | 276 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2. | 268 |
| Total | 826 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 13 | 11 |
| Overall Study | Lost to Follow-up | 8 | 6 | 4 |
| Overall Study | Other-Lack of efficacy | 1 | 0 | 0 |
| Overall Study | Other-Refused follow-up visit | 1 | 0 | 0 |
| Overall Study | Other-Relocation | 0 | 1 | 0 |
| Overall Study | Other-Repeat safety labs-exclusionary | 0 | 1 | 0 |
| Overall Study | Other-Scheduled gastroplasty | 1 | 0 | 0 |
| Overall Study | Other-Study medication lost | 0 | 0 | 1 |
| Overall Study | Other-Subject moved out of country | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 16 | 7 | 10 |
| Overall Study | Withdrawal by Subject | 14 | 14 | 12 |
Baseline characteristics
| Characteristic | Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Total | Placebo Tablets and Nonhormonal Vaginal Lubricant |
|---|---|---|---|---|
| Age Continuous | 58.6 Years STANDARD_DEVIATION 6.34 | 58.4 Years STANDARD_DEVIATION 6.27 | 58.6 Years STANDARD_DEVIATION 6.23 | 58.9 Years STANDARD_DEVIATION 6.09 |
| Body Mass Index (BMI) | 26.0 kg/m^2 STANDARD_DEVIATION 4.44 | 26.4 kg/m^2 STANDARD_DEVIATION 4.51 | 26.2 kg/m^2 STANDARD_DEVIATION 4.43 | 26.1 kg/m^2 STANDARD_DEVIATION 4.37 |
| Currently Experiencing Hot Flashes? No | 102 Participants | 110 Participants | 325 Participants | 113 Participants |
| Currently Experiencing Hot Flashes? Yes | 174 Participants | 172 Participants | 501 Participants | 155 Participants |
| Height | 162.1 cm STANDARD_DEVIATION 6.42 | 161.9 cm STANDARD_DEVIATION 6.6 | 162.1 cm STANDARD_DEVIATION 6.62 | 162.3 cm STANDARD_DEVIATION 6.87 |
| Intact Cervix? No | 143 Participants | 149 Participants | 431 Participants | 139 Participants |
| Intact Cervix? Yes | 133 Participants | 133 Participants | 395 Participants | 129 Participants |
| Intact Uterus? No | 148 Participants | 153 Participants | 447 Participants | 146 Participants |
| Intact Uterus? Yes | 128 Participants | 129 Participants | 379 Participants | 122 Participants |
| MBS-Difficult/Painful Urination at Randomization Moderate | 1 Participants | 2 Participants | 5 Participants | 2 Participants |
| MBS-Difficult/Painful Urination at Randomization Severe | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization Mild | 4 Participants | 2 Participants | 9 Participants | 3 Participants |
| MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization Moderate | 17 Participants | 25 Participants | 66 Participants | 24 Participants |
| MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization None | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization Severe | 9 Participants | 11 Participants | 29 Participants | 9 Participants |
| MBS-Vaginal Bleeding with Sexual Activity at Randomization Moderate | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| MBS-Vaginal Bleeding with Sexual Activity at Randomization None | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| MBS-Vaginal Bleeding with Sexual Activity at Randomization Severe | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| MBS-Vaginal Dryness at Randomization Mild | 4 Participants | 3 Participants | 8 Participants | 1 Participants |
| MBS-Vaginal Dryness at Randomization Moderate | 61 Participants | 47 Participants | 170 Participants | 62 Participants |
| MBS-Vaginal Dryness at Randomization Severe | 53 Participants | 52 Participants | 146 Participants | 41 Participants |
| MBS-Vaginal Pain with Sexual Activity at Randomization Mild | 3 Participants | 3 Participants | 7 Participants | 1 Participants |
| MBS-Vaginal Pain with Sexual Activity at Randomization Moderate | 29 Participants | 46 Participants | 108 Participants | 33 Participants |
| MBS-Vaginal Pain with Sexual Activity at Randomization None | 4 Participants | 3 Participants | 9 Participants | 2 Participants |
| MBS-Vaginal Pain with Sexual Activity at Randomization Severe | 84 Participants | 84 Participants | 254 Participants | 86 Participants |
| Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite]) Mild | 11 Participants | 8 Participants | 24 Participants | 5 Participants |
| Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite]) Moderate | 109 Participants | 121 Participants | 351 Participants | 121 Participants |
| Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite]) None | 5 Participants | 4 Participants | 12 Participants | 3 Participants |
| Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite]) Severe | 150 Participants | 148 Participants | 434 Participants | 136 Participants |
| No. of Days with Hot Flashes (/month) | 19.6 Days STANDARD_DEVIATION 11.49 | 19.7 Days STANDARD_DEVIATION 11.68 | 19.6 Days STANDARD_DEVIATION 11.41 | 19.6 Days STANDARD_DEVIATION 11.09 |
| No. of Urinary Tract Infections in Past 6 Months 0 | 239 Participants | 247 Participants | 728 Participants | 242 Participants |
| No. of Urinary Tract Infections in Past 6 Months 1 | 24 Participants | 27 Participants | 68 Participants | 17 Participants |
| No. of Urinary Tract Infections in Past 6 Months 2 | 9 Participants | 7 Participants | 24 Participants | 8 Participants |
| No. of Urinary Tract Infections in Past 6 Months 3 | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| No. of Urinary Tract Infections in Past 6 Months 4 or more | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| No. of Urinary Tract Infections in Past 6 Months Missing values | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| No. of Vaginal Births | 1.65 Vaginal births per participant STANDARD_DEVIATION 1.478 | 1.78 Vaginal births per participant STANDARD_DEVIATION 1.565 | 1.68 Vaginal births per participant STANDARD_DEVIATION 1.48 | 1.59 Vaginal births per participant STANDARD_DEVIATION 1.386 |
| Number (No.) of Pregnancies | 2.39 Pregnancies per participant STANDARD_DEVIATION 1.638 | 2.61 Pregnancies per participant STANDARD_DEVIATION 1.834 | 2.46 Pregnancies per participant STANDARD_DEVIATION 1.675 | 2.38 Pregnancies per participant STANDARD_DEVIATION 1.525 |
| Percentage of Parabasal Cells at Screening | 39.3 Percentage of Parabasal Cells STANDARD_DEVIATION 38.98 | 40.1 Percentage of Parabasal Cells STANDARD_DEVIATION 38.33 | 39.3 Percentage of Parabasal Cells STANDARD_DEVIATION 38.28 | 38.5 Percentage of Parabasal Cells STANDARD_DEVIATION 37.6 |
| Percentage of Superficial Cells at Screening | 1.04 Percentage of Superficial Cells STANDARD_DEVIATION 3.368 | 1.25 Percentage of Superficial Cells STANDARD_DEVIATION 2.907 | 1.07 Percentage of Superficial Cells STANDARD_DEVIATION 2.989 | 0.91 Percentage of Superficial Cells STANDARD_DEVIATION 2.635 |
| Previous Hormone Treatment No | 222 Partcipants | 232 Partcipants | 672 Partcipants | 218 Partcipants |
| Previous Hormone Treatment Yes | 54 Partcipants | 50 Partcipants | 154 Partcipants | 50 Partcipants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 15 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants | 18 Participants | 50 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 20 Participants | 17 Participants | 61 Participants | 24 Participants |
| Race/Ethnicity, Customized Missing value | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 256 Participants | 265 Participants | 765 Participants | 244 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 6 Participants | 12 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 249 Participants | 253 Participants | 744 Participants | 242 Participants |
| Sex: Female, Male Female | 276 Participants | 282 Participants | 826 Participants | 268 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Vaginal pH at Screening | 6.37 Vaginal pH STANDARD_DEVIATION 0.763 | 6.35 Vaginal pH STANDARD_DEVIATION 0.736 | 6.35 Vaginal pH STANDARD_DEVIATION 0.743 | 6.34 Vaginal pH STANDARD_DEVIATION 0.732 |
| Weight | 68.4 kg STANDARD_DEVIATION 12.08 | 69.2 kg STANDARD_DEVIATION 13.06 | 68.9 kg STANDARD_DEVIATION 12.68 | 69.0 kg STANDARD_DEVIATION 12.9 |
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 | 99 / 282 | 99 / 276 | 49 / 268 |
| serious Total, serious adverse events | 5 / 282 | 0 / 276 | 4 / 268 |
Outcome results
Primary
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | -21.9 percentage of parabasal cells | Standard Deviation 32.6 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | -30.1 percentage of parabasal cells | Standard Deviation 37.93 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear | 3.98 percentage of parabasal cells | Standard Deviation 35.205 |
Primary
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Time frame: Baseline (Randomization) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | -1.02 Units on a scale | Standard Deviation 1.132 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | -1.19 Units on a scale | Standard Deviation 1.292 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | -0.89 Units on a scale | Standard Deviation 1.115 |
Primary
Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness
This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Time frame: Baseline (Randomization) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | -1.22 Units on a scale | Standard Deviation 0.929 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | -1.26 Units on a scale | Standard Deviation 1.025 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | -0.84 Units on a scale | Standard Deviation 0.996 |
Primary
Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | 7.78 percentage of superficial cells | Standard Deviation 12.136 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | 10.8 percentage of superficial cells | Standard Deviation 15.66 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear | 2.18 percentage of superficial cells | Standard Deviation 8.393 |
Primary
Mean Change From Baseline in Vaginal pH
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Vaginal pH | -0.67 pH | Standard Deviation 1.054 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Vaginal pH | -1.01 pH | Standard Deviation 1.053 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Mean Change From Baseline in Vaginal pH | -0.096 pH | Standard Deviation 0.8357 |
Secondary
Change From Baseline in Estradiol Levels
Time frame: Baseline (Screening) to Week 12
Population: Analysis populations for each hormone:~Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Estradiol Levels | -1.44 pg/mL | Standard Deviation 19.01 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Estradiol Levels | 1.02 pg/mL | Standard Deviation 12.74 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Estradiol Levels | 0.30 pg/mL | Standard Deviation 3.9 |
Secondary
Change From Baseline in Follicle Stimulating Hormone Levels
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Follicle Stimulating Hormone Levels | -5.93 IU/L | Standard Deviation 12.49 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Follicle Stimulating Hormone Levels | -8.71 IU/L | Standard Deviation 13.61 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Follicle Stimulating Hormone Levels | -1.33 IU/L | Standard Deviation 10.87 |
Secondary
Change From Baseline in Luteinizing Hormone Levels
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Luteinizing Hormone Levels | -2.85 IU/L | Standard Deviation 6.07 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Luteinizing Hormone Levels | -3.73 IU/L | Standard Deviation 5.83 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Luteinizing Hormone Levels | 0.41 IU/L | Standard Deviation 7.25 |
Secondary
Change From Baseline in Severity of VVA Symptoms
This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Time frame: Baseline (Randomization) to Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Difficult/painful urination | -0.17 Units on a scale | Standard Deviation 0.676 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vulvar/vaginal itching or irritation | -0.40 Units on a scale | Standard Deviation 1.08 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal dryness | -0.96 Units on a scale | Standard Deviation 1.018 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal pain associated with sexual activity | -0.77 Units on a scale | Standard Deviation 1.2 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal bleeding associated with sexual activity | -0.26 Units on a scale | Standard Deviation 0.807 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vulvar/vaginal itching or irritation | -0.58 Units on a scale | Standard Deviation 0.982 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal dryness | -1.17 Units on a scale | Standard Deviation 1.05 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal pain associated with sexual activity | -0.87 Units on a scale | Standard Deviation 1.278 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Difficult/painful urination | -0.20 Units on a scale | Standard Deviation 0.673 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal bleeding associated with sexual activity | -0.23 Units on a scale | Standard Deviation 0.707 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal bleeding associated with sexual activity | -0.12 Units on a scale | Standard Deviation 0.667 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Difficult/painful urination | -0.097 Units on a scale | Standard Deviation 0.6745 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal dryness | -0.63 Units on a scale | Standard Deviation 1.047 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vulvar/vaginal itching or irritation | -0.44 Units on a scale | Standard Deviation 0.948 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Severity of VVA Symptoms | Vaginal pain associated with sexual activity | -0.57 Units on a scale | Standard Deviation 1.224 |
Secondary
Change From Baseline in Sex Hormone Binding Globulin Levels
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Sex Hormone Binding Globulin Levels | 11.1 nmol/L | Standard Deviation 16.46 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Sex Hormone Binding Globulin Levels | 22.8 nmol/L | Standard Deviation 22.06 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Sex Hormone Binding Globulin Levels | -2.17 nmol/L | Standard Deviation 12.02 |
Secondary
Change From Baseline in Testosterone (Free) Levels
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Free) Levels | 0.002 ng/dL | Standard Deviation 0.51 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Free) Levels | -0.031 ng/dL | Standard Deviation 0.15 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Free) Levels | -0.008 ng/dL | Standard Deviation 0.13 |
Secondary
Change From Baseline in Testosterone (Total) Levels
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Total) Levels | 1.55 ng/dL | Standard Deviation 18.82 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Total) Levels | 1.92 ng/dL | Standard Deviation 5.56 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Testosterone (Total) Levels | -0.059 ng/dL | Standard Deviation 6.07 |
Secondary
Change From Baseline in Urinary Symptoms
Time frame: Baseline (Randomization) to Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Improved | 49 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Worsened | 24 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Improved | 52 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Worsened | 24 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Improved | 50 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Worsened | 24 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Improved | 59 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Worsened | 30 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Improved | 25 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Worsened | 14 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal/genital area-Improved | 37 Participants |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal or genital area-Worsened | 17 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal or genital area-Worsened | 13 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Improved | 63 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Improved | 55 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Improved | 26 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Worsened | 25 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Worsened | 23 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal/genital area-Improved | 41 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Improved | 53 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Worsened | 32 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Improved | 56 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Worsened | 26 Participants |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Worsened | 11 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Worsened | 32 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Improved | 47 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Worsened | 15 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage with physical exertion-Worsened | 27 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Improved | 58 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Small amount of urine leakage-Worsened | 27 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal/genital area-Improved | 37 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Improved | 60 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Frequent urination-Worsened | 22 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Difficulty emptying bladder-Improved | 24 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Urine leakage (feeling of urgency)-Improved | 57 Participants |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Urinary Symptoms | Pain in lower abdominal or genital area-Worsened | 16 Participants |
Secondary
Change From Baseline in Visual Evaluation of the Vagina
Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Time frame: Baseline (Screening) to Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal dryness in mucosa | -1.05 Units on a scale | Standard Deviation 0.959 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.57 Units on a scale | Standard Deviation 0.922 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.50 Units on a scale | Standard Deviation 0.829 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -0.75 Units on a scale | Standard Deviation 0.914 |
| Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal redness in mucosa | -0.44 Units on a scale | Standard Deviation 0.811 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.71 Units on a scale | Standard Deviation 0.911 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.60 Units on a scale | Standard Deviation 0.848 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -0.93 Units on a scale | Standard Deviation 0.93 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal dryness in mucosa | -1.22 Units on a scale | Standard Deviation 0.981 |
| Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal redness in mucosa | -0.60 Units on a scale | Standard Deviation 0.924 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal redness in mucosa | -0.23 Units on a scale | Standard Deviation 0.792 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Vaginal dryness in mucosa | -0.48 Units on a scale | Standard Deviation 0.911 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Petechiae | -0.037 Units on a scale | Standard Deviation 0.808 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Friability | -0.16 Units on a scale | Standard Deviation 0.818 |
| Placebo Tablets and Nonhormonal Vaginal Lubricant | Change From Baseline in Visual Evaluation of the Vagina | Pallor | -0.30 Units on a scale | Standard Deviation 0.94 |