Postmenopausal Vulvovaginal Atrophy
Conditions
Keywords
Postmenopausal Women, Vaginal Dryness
Brief summary
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
Interventions
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
DRUGVehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness
Exclusion criteria
* Hypersensitivity to estrogen and/or progestin therapy * Known or suspected premalignant or malignant disease (except successfully treated skin cancers) * Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks * Insulin-dependent diabetes mellitus * Increased frequency or severity of headaches while on hormone or estrogen therapy * Drug or alcohol addiction within last 2 years * Participation in a clinical trial within 30 days * Smoking ≥ 15 cigarettes daily * Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Baseline (Day 0) to Week 12/Final Visit | The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Vaginal pH to Week 12/Final Visit | Baseline (Day 0) to Week 12/Final Visit | Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Baseline (Day 0) to Week 12/Final Visit | Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Baseline (Day 0) to Week 12/Final Visit | Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Baseline (Day 0) to Week 12 and Week 12/Final visit | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Baseline (Day 0) to Weeks 2, 4, 8 and 12 | Participant's self-assessment of symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. |
| Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit | Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit | Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Baseline (Day 0) to Week 12 and Week 12/Final visit | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit | Vaginal bleeding associated with sexual activity was assessed by participants as either present or absent. Percentage of participants with assessment present are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Vaginal pH to Week 12 | Baseline (Day 0) to Week 12 | Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. |
| Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Baseline (Day 0) to Week 12 | Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. |
| Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Baseline (Day 0) to Week 12 | Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. |
| Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit | Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Baseline (Day 0) to Week 12 and Week 12/Final visit | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Baseline (Day 0) to Week 12 and Week 12/Final visit | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
| Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Baseline (Day 0) to Week 12 and Week 12/Final visit | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. | 238 |
| Vehicle (2 Times/Week) Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. | 124 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. | 237 |
| Vehicle (3 Times/Week) Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. | 123 |
| Total | 722 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 | 9 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 4 | 1 |
| Overall Study | Protocol Deviation | 6 | 1 | 5 | 2 |
| Overall Study | Reason not Specified | 3 | 0 | 4 | 3 |
| Overall Study | Withdrew Consent | 4 | 2 | 6 | 1 |
Baseline characteristics
| Characteristic | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 6.27 | 57.8 years STANDARD_DEVIATION 6.34 | 58.0 years STANDARD_DEVIATION 6.03 | 58.7 years STANDARD_DEVIATION 6.58 | 58.2 years STANDARD_DEVIATION 6.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 6 Participants | 15 Participants | 10 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 224 Participants | 118 Participants | 222 Participants | 113 Participants | 677 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 18 Participants | 27 Participants | 14 Participants | 88 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 202 Participants | 105 Participants | 208 Participants | 106 Participants | 621 Participants |
| Sex: Female, Male Female | 238 Participants | 124 Participants | 237 Participants | 123 Participants | 722 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
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 | 0 / 238 | 0 / 124 | 0 / 237 | 0 / 123 |
| other Total, other adverse events | 46 / 238 | 20 / 124 | 57 / 237 | 23 / 123 |
| serious Total, serious adverse events | 1 / 238 | 0 / 124 | 0 / 237 | 1 / 123 |
Outcome results
Primary
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12/Final Visit
Population: Modified Intent-to-Treat Population (mITT) included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Baseline | 2.49 score on a scale | Standard Deviation 0.5 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.27 score on a scale | Standard Deviation 0.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.99 score on a scale | Standard Deviation 0.89 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Baseline | 2.46 score on a scale | Standard Deviation 0.52 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Baseline | 2.50 score on a scale | Standard Deviation 0.5 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.31 score on a scale | Standard Deviation 0.93 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Baseline | 2.50 score on a scale | Standard Deviation 0.5 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.17 score on a scale | Standard Deviation 0.97 |
Primary
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12/Final Visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | 41.7 percentage of parabasal cells | Standard Deviation 42.76 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Baseline | 48.36 percentage of parabasal cells | Standard Deviation 43.46 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Baseline | 47.78 percentage of parabasal cells | Standard Deviation 44.51 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -8.20 percentage of parabasal cells | Standard Deviation 29.56 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Baseline | 42.56 percentage of parabasal cells | Standard Deviation 41.03 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -38.5 percentage of parabasal cells | Standard Deviation 39.78 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -16.0 percentage of parabasal cells | Standard Deviation 32.75 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit | Baseline | 45.24 percentage of parabasal cells | Standard Deviation 42.47 |
Primary
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12/Final Visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | 11.44 percentage of superficial cells | Standard Deviation 14.74 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Baseline | 0.85 percentage of superficial cells | Standard Deviation 3.76 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Baseline | 0.66 percentage of superficial cells | Standard Deviation 1.62 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | 3.05 percentage of superficial cells | Standard Deviation 7.11 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Baseline | 0.79 percentage of superficial cells | Standard Deviation 1.63 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | 17.30 percentage of superficial cells | Standard Deviation 19.27 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | 4.02 percentage of superficial cells | Standard Deviation 12.16 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit | Baseline | 0.66 percentage of superficial cells | Standard Deviation 1.21 |
Primary
Change From Baseline in Vaginal pH to Week 12/Final Visit
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12/Final Visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Baseline | 6.51 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.08 score on a scale | Standard Deviation 1.14 |
| Vehicle (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.37 score on a scale | Standard Deviation 0.92 |
| Vehicle (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Baseline | 6.49 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Baseline | 6.40 score on a scale | Standard Deviation 0.93 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.99 score on a scale | Standard Deviation 1.05 |
| Vehicle (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Baseline | 6.40 score on a scale | Standard Deviation 0.86 |
| Vehicle (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.46 score on a scale | Standard Deviation 0.9 |
Secondary
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Baseline | 1.88 score on a scale | Standard Deviation 0.6 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.74 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.77 score on a scale | Standard Deviation 0.8 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Baseline | 1.94 score on a scale | Standard Deviation 0.7 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.48 score on a scale | Standard Deviation 0.72 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.47 score on a scale | Standard Deviation 0.71 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.76 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Baseline | 1.90 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.75 score on a scale | Standard Deviation 0.81 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Baseline | 1.88 score on a scale | Standard Deviation 0.63 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.44 score on a scale | Standard Deviation 0.77 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.44 score on a scale | Standard Deviation 0.76 |
Secondary
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.64 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Baseline | 1.04 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.66 score on a scale | Standard Deviation 0.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.47 score on a scale | Standard Deviation 0.86 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Baseline | 1.02 score on a scale | Standard Deviation 0.94 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.48 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.60 score on a scale | Standard Deviation 0.87 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Baseline | 0.94 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.61 score on a scale | Standard Deviation 0.86 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Baseline | 1.04 score on a scale | Standard Deviation 0.93 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.52 score on a scale | Standard Deviation 0.89 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.52 score on a scale | Standard Deviation 0.89 |
Secondary
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.73 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.71 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Baseline | 1.76 score on a scale | Standard Deviation 0.67 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Baseline | 1.72 score on a scale | Standard Deviation 0.76 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.39 score on a scale | Standard Deviation 0.76 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.36 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.78 score on a scale | Standard Deviation 0.79 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Baseline | 1.74 score on a scale | Standard Deviation 0.7 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.77 score on a scale | Standard Deviation 0.8 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Baseline | 1.83 score on a scale | Standard Deviation 0.67 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.59 score on a scale | Standard Deviation 0.81 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.59 score on a scale | Standard Deviation 0.81 |
Secondary
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Baseline | 0.74 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.44 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.47 score on a scale | Standard Deviation 0.74 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Baseline | 0.89 score on a scale | Standard Deviation 0.89 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.40 score on a scale | Standard Deviation 0.71 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.38 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.47 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Baseline | 0.70 score on a scale | Standard Deviation 0.83 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.46 score on a scale | Standard Deviation 0.82 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Baseline | 0.71 score on a scale | Standard Deviation 0.81 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.30 score on a scale | Standard Deviation 0.75 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.29 score on a scale | Standard Deviation 0.73 |
Secondary
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.94 score on a scale | Standard Deviation 0.88 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Baseline | 1.92 score on a scale | Standard Deviation 0.68 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.91 score on a scale | Standard Deviation 0.89 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.53 score on a scale | Standard Deviation 0.82 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.55 score on a scale | Standard Deviation 0.83 |
| Vehicle (2 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Baseline | 1.85 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.89 score on a scale | Standard Deviation 0.9 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.90 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Baseline | 1.83 score on a scale | Standard Deviation 0.75 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Baseline | 1.87 score on a scale | Standard Deviation 0.76 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.74 score on a scale | Standard Deviation 0.91 |
| Vehicle (3 Times/Week) | Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.76 score on a scale | Standard Deviation 0.92 |
Secondary
Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 2.29 score on a scale | Standard Deviation 0.93 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.79 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -1.04 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -1.08 score on a scale | Standard Deviation 1.01 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -1.15 score on a scale | Standard Deviation 1.09 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.15 score on a scale | Standard Deviation 1.07 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.03 score on a scale | Standard Deviation 1 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -1.04 score on a scale | Standard Deviation 0.96 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 2.23 score on a scale | Standard Deviation 0.88 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -1.03 score on a scale | Standard Deviation 0.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.78 score on a scale | Standard Deviation 1.07 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -1.06 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.86 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -1.06 score on a scale | Standard Deviation 1.03 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -1.36 score on a scale | Standard Deviation 0.97 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.35 score on a scale | Standard Deviation 1.02 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -1.39 score on a scale | Standard Deviation 1.01 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 2.29 score on a scale | Standard Deviation 0.85 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -1.09 score on a scale | Standard Deviation 1.05 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -1.06 score on a scale | Standard Deviation 1.07 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.67 score on a scale | Standard Deviation 1.01 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -1.07 score on a scale | Standard Deviation 1.09 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 2.38 score on a scale | Standard Deviation 0.86 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.78 score on a scale | Standard Deviation 0.91 |
Secondary
Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 0.38 score on a scale | Standard Deviation 0.7 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.24 score on a scale | Standard Deviation 0.67 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.20 score on a scale | Standard Deviation 0.68 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.20 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.28 score on a scale | Standard Deviation 0.68 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.27 score on a scale | Standard Deviation 0.66 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.27 score on a scale | Standard Deviation 0.64 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.28 score on a scale | Standard Deviation 0.72 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 0.49 score on a scale | Standard Deviation 0.75 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.30 score on a scale | Standard Deviation 0.6 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.22 score on a scale | Standard Deviation 0.71 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.28 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.28 score on a scale | Standard Deviation 0.74 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.28 score on a scale | Standard Deviation 0.76 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.32 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.34 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.36 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 0.45 score on a scale | Standard Deviation 0.75 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.41 score on a scale | Standard Deviation 0.79 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.39 score on a scale | Standard Deviation 0.78 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.38 score on a scale | Standard Deviation 0.77 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.34 score on a scale | Standard Deviation 0.85 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 0.53 score on a scale | Standard Deviation 0.8 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.42 score on a scale | Standard Deviation 0.77 |
Secondary
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12
Participant's self-assessment of symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8 and 12
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Baseline | 2.49 score on a scale | Standard Deviation 0.5 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 8 | -1.25 score on a scale | Standard Deviation 0.84 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 12 | -1.30 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 2 | -0.83 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 4 | -1.07 score on a scale | Standard Deviation 0.82 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 2 | -0.79 score on a scale | Standard Deviation 0.88 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 12 | -0.97 score on a scale | Standard Deviation 0.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Baseline | 2.46 score on a scale | Standard Deviation 0.52 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 4 | -0.93 score on a scale | Standard Deviation 0.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 8 | -1.02 score on a scale | Standard Deviation 0.9 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Baseline | 2.50 score on a scale | Standard Deviation 0.5 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 2 | -0.95 score on a scale | Standard Deviation 0.9 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 4 | -1.12 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 8 | -1.43 score on a scale | Standard Deviation 0.9 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 12 | -1.36 score on a scale | Standard Deviation 0.94 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 2 | -0.79 score on a scale | Standard Deviation 0.84 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 12 | -1.20 score on a scale | Standard Deviation 0.98 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Baseline | 2.50 score on a scale | Standard Deviation 0.5 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 8 | -1.11 score on a scale | Standard Deviation 0.91 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 | Change from Baseline to Week 4 | -0.95 score on a scale | Standard Deviation 0.9 |
Secondary
Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.54 score on a scale | Standard Deviation 1.09 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.74 score on a scale | Standard Deviation 1.01 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.71 score on a scale | Standard Deviation 1.11 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.75 score on a scale | Standard Deviation 1.03 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 1.26 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.62 score on a scale | Standard Deviation 1.14 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 1.33 score on a scale | Standard Deviation 1 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.67 score on a scale | Standard Deviation 0.95 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.71 score on a scale | Standard Deviation 0.92 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.82 score on a scale | Standard Deviation 1.03 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.74 score on a scale | Standard Deviation 1.02 |
| Vehicle (2 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.74 score on a scale | Standard Deviation 1.03 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 1.11 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.48 score on a scale | Standard Deviation 1.08 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.58 score on a scale | Standard Deviation 1.02 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.59 score on a scale | Standard Deviation 1.04 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.48 score on a scale | Standard Deviation 1.05 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.57 score on a scale | Standard Deviation 0.97 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 2 | -0.48 score on a scale | Standard Deviation 1.04 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 1.20 score on a scale | Standard Deviation 0.89 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 4 | -0.65 score on a scale | Standard Deviation 1.01 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 8 | -0.58 score on a scale | Standard Deviation 1 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12/Final Visit | -0.63 score on a scale | Standard Deviation 0.92 |
| Vehicle (3 Times/Week) | Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Change from Baseline to Week 12 | -0.70 score on a scale | Standard Deviation 0.86 |
Secondary
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells.
Time frame: Baseline (Day 0) to Week 12
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Change from Baseline to Week 12 | -42.3 percentage of parabasal cells | Standard Deviation 42.9 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Baseline | 48.36 percentage of parabasal cells | Standard Deviation 43.46 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Change from Baseline to Week 12 | -8.08 percentage of parabasal cells | Standard Deviation 29.9 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Baseline | 47.78 percentage of parabasal cells | Standard Deviation 44.51 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Baseline | 42.56 percentage of parabasal cells | Standard Deviation 41.03 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Change from Baseline to Week 12 | -39.5 percentage of parabasal cells | Standard Deviation 39.46 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Baseline | 45.24 percentage of parabasal cells | Standard Deviation 42.47 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12 | Change from Baseline to Week 12 | -14.9 percentage of parabasal cells | Standard Deviation 31.93 |
Secondary
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells.
Time frame: Baseline (Day 0) to Week 12
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Baseline | 0.85 percentage of superficial cells | Standard Deviation 3.76 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Change from Baseline to Week 12 | 11.66 percentage of superficial cells | Standard Deviation 14.51 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Change from Baseline to Week 12 | 3.17 percentage of superficial cells | Standard Deviation 7.02 |
| Vehicle (2 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Baseline | 0.66 percentage of superficial cells | Standard Deviation 1.62 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Baseline | 0.79 percentage of superficial cells | Standard Deviation 1.63 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Change from Baseline to Week 12 | 17.66 percentage of superficial cells | Standard Deviation 19.37 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Baseline | 0.66 percentage of superficial cells | Standard Deviation 1.21 |
| Vehicle (3 Times/Week) | Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12 | Change from Baseline to Week 12 | 3.36 percentage of superficial cells | Standard Deviation 10.31 |
Secondary
Change From Baseline in Vaginal pH to Week 12
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 0) to Week 12
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Baseline | 6.51 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Change from Baseline to Week 12 | -1.10 score on a scale | Standard Deviation 1.15 |
| Vehicle (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Change from Baseline to Week 12 | -0.34 score on a scale | Standard Deviation 0.89 |
| Vehicle (2 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Baseline | 6.49 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Baseline | 6.40 score on a scale | Standard Deviation 0.93 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Change from Baseline to Week 12 | -1.01 score on a scale | Standard Deviation 1.06 |
| Vehicle (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Baseline | 6.40 score on a scale | Standard Deviation 0.86 |
| Vehicle (3 Times/Week) | Change From Baseline in Vaginal pH to Week 12 | Change from Baseline to Week 12 | -0.47 score on a scale | Standard Deviation 0.87 |
Secondary
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit
Vaginal bleeding associated with sexual activity was assessed by participants as either present or absent. Percentage of participants with assessment present are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Time frame: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
Population: mITT Population included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 15.81 percentage of participants |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 2 | 6.55 percentage of participants |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 4 | 5.29 percentage of participants |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 8 | 4.61 percentage of participants |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12 | 6.94 percentage of participants |
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12/Final Visit | 6.44 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12/Final Visit | 4.88 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 8 | 4.96 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 17.89 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 4 | 6.50 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 2 | 7.32 percentage of participants |
| Vehicle (2 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12 | 5.04 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 2 | 6.11 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 4 | 2.64 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 8 | 2.74 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12/Final Visit | 3.03 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12 | 3.35 percentage of participants |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 17.75 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12 | 6.19 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 12/Final Visit | 5.79 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 2 | 9.24 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 8 | 6.90 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Baseline | 24.79 percentage of participants |
| Vehicle (3 Times/Week) | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit | Week 4 | 5.00 percentage of participants |