Vulvovaginal Atrophy
Conditions
Keywords
Postmenopausal Women, Vaginal Dryness, Postmenopausal Vulvovaginal Atrophy
Brief summary
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
Interventions
WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Sponsors
Warner Chilcott
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed Study PR-04409.3 (NCT01400776)
Exclusion criteria
Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011: * 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, stroke or ischemic attack * Insulin-dependent diabetes mellitus * Smoking ≥ 15 cigarettes daily * Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Endometrial Biopsy Results at Final Visit | Final Visit (Day closest to Day 281) | The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness \>4 mm, missing biopsy with endometrial thickness \>4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281) | 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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study. |
| Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281) | 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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study. |
| Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Weeks 4, 8, 16, 24, 32, 40 and Final Visit (Day closest to Day 281) | Self-Assessment of the symptoms of VVA was evaluated for vaginal dryness, vaginal Itching, dysuria, and dyspareunia by a questionnaire. Questionnaire consisted of 5 questions scaled from 0 to 3 level of intensity, where 0-none indicated symptom not present; 1-mild indicated symptom is present but may be intermittent; does not interfere with your activities or lifestyle; 2-moderate indicated symptom is present, aware of the symptom but activities and lifestyle are only occasionally affected; 3-severe indicated usually aware and bothered by the symptom and have modified your activities and/or lifestyle due to the symptom. Higher score indicated most bothersome symptoms. A negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study. |
| Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281) | Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3= severe. The negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study. |
| Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | Up to Week 40 | An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. TEAE are defined as those AEs with onset date on or after the first dose date of study drug in Study PR-04509, or adverse events that worsen after the first dose date of study drug in Study PR-04509. |
| Change From Baseline in Vaginal pH | Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281) | Vaginal pH was obtained at final visit of the study. The pH was a numeric value from 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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study. |
Countries
United States
Participant flow
Pre-assignment details
Participants who completed study PR-04409.3 (NCT01400776) were enrolled to receive W13011 estradiol vaginal cream three times a week in this study. Participant flow and outcome measures data were summarized as per treatment received in previous study.
Participants by arm
| Arm | Count |
|---|---|
| WC3011 Estradiol Vaginal Cream WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks. | 308 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 0 | 5 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 | 2 | 1 |
| Overall Study | Reason not Specified | 1 | 2 | 3 | 3 |
| Overall Study | Withdrew Consent | 6 | 5 | 8 | 5 |
Baseline characteristics
| Characteristic | WC3011 Estradiol Vaginal Cream |
|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 5.54 |
| Sex: Female, Male Female | 308 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 308 |
| other Total, other adverse events | 50 / 308 |
| serious Total, serious adverse events | 8 / 308 |
Outcome results
Primary
Number of Participants With Endometrial Biopsy Results at Final Visit
The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness \>4 mm, missing biopsy with endometrial thickness \>4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509.
Time frame: Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Data is reported as per the duration of exposure of participants receiving study treatment. Overall number analyzed is the number of participants with available data at the given timepoint. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy Without TVU Result | 3 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Abnormal Biopsy: Polyp | 0 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm | 1 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory Without TVU Result | 0 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Proliferative | 0 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Atrophic | 3 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy With Endometrial Thickness >4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory With Endometrial Thickness >4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory Without TVU Result | 2 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Atrophic | 10 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Proliferative | 1 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm | 3 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm | 1 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Abnormal Biopsy: Polyp | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory With Endometrial Thickness >4 mm | 1 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy With Endometrial Thickness >4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy Without TVU Result | 9 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm | 4 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Abnormal Biopsy: Polyp | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory With Endometrial Thickness >4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Proliferative | 1 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy Without TVU Result | 6 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy With Endometrial Thickness >4 mm | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory Without TVU Result | 0 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm | 1 Participants |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Atrophic | 7 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory Without TVU Result | 3 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy With Endometrial Thickness >4 mm | 1 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Abnormal Biopsy: Polyp | 1 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Proliferative | 3 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Missing Biopsy Without TVU Result | 6 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Atrophic | 166 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Unknown: Unsatisfactory With Endometrial Thickness >4 mm | 6 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm | 21 Participants |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Number of Participants With Endometrial Biopsy Results at Final Visit | Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm | 48 Participants |
Secondary
Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3= severe. The negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.
Time frame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.79 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Week 40 | -0.4 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Baseline | 1.1 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Week 40 | -0.2 score on a scale | Standard Deviation 0.57 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Final Visit | -0.4 score on a scale | Standard Deviation 0.83 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Week 40 | -0.4 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline at Week 40 | -0.1 score on a scale | Standard Deviation 0.45 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Baseline | 1.0 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Baseline | 1.1 score on a scale | Standard Deviation 0.7 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Baseline | 0.4 score on a scale | Standard Deviation 0.67 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Baseline | 0.3 score on a scale | Standard Deviation 0.63 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 0.44 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 0.55 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Final Visit | -0.4 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Baseline | 0.6 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Final Visit | -0.4 score on a scale | Standard Deviation 0.88 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Baseline | 0.6 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Baseline | 1.5 score on a scale | Standard Deviation 0.76 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline at Week 40 | -0.5 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline to Final Visit | -0.5 score on a scale | Standard Deviation 0.79 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Baseline | 1.5 score on a scale | Standard Deviation 0.83 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Week 40 | -0.8 score on a scale | Standard Deviation 1 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Baseline | 1.4 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Week 40 | -1.0 score on a scale | Standard Deviation 0.92 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Final Visit | -0.8 score on a scale | Standard Deviation 0.97 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Week 40 | -0.7 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.99 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.85 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Baseline | 0.2 score on a scale | Standard Deviation 0.59 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Baseline | 0.3 score on a scale | Standard Deviation 0.59 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Week 40 | -0.4 score on a scale | Standard Deviation 0.87 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 0.84 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 0.54 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.92 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline at Week 40 | -0.1 score on a scale | Standard Deviation 0.56 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Baseline | 1.1 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.79 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Week 40 | -0.2 score on a scale | Standard Deviation 0.67 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Baseline | 1.0 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Baseline | 1.0 score on a scale | Standard Deviation 0.74 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Baseline | 0.4 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 0.63 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Baseline | 1.4 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Atrophy-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.84 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Baseline | 1.3 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Pallor-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Baseline | 1.1 score on a scale | Standard Deviation 1.01 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Week 40 | -0.4 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Dryness-Change From Baseline to Final Visit | -0.5 score on a scale | Standard Deviation 0.94 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Baseline | 0.5 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Week 40 | -0.2 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Friability-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA | Petechiae-Change From Baseline at Week 40 | -0.1 score on a scale | Standard Deviation 0.65 |
Secondary
Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints
Self-Assessment of the symptoms of VVA was evaluated for vaginal dryness, vaginal Itching, dysuria, and dyspareunia by a questionnaire. Questionnaire consisted of 5 questions scaled from 0 to 3 level of intensity, where 0-none indicated symptom not present; 1-mild indicated symptom is present but may be intermittent; does not interfere with your activities or lifestyle; 2-moderate indicated symptom is present, aware of the symptom but activities and lifestyle are only occasionally affected; 3-severe indicated usually aware and bothered by the symptom and have modified your activities and/or lifestyle due to the symptom. Higher score indicated most bothersome symptoms. A negative change from Baseline indicates improvement. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.
Time frame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Weeks 4, 8, 16, 24, 32, 40 and Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Baseline | 0.1 score on a scale | Standard Deviation 0.42 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Final Visit | -0.4 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 40 | -0.6 score on a scale | Standard Deviation 0.99 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 32 | -0.2 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 24 | -0.3 score on a scale | Standard Deviation 0.74 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Baseline | 0.6 score on a scale | Standard Deviation 0.73 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 32 | -0.5 score on a scale | Standard Deviation 0.95 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 16 | -0.3 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 8 | -0.2 score on a scale | Standard Deviation 0.74 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 24 | -0.6 score on a scale | Standard Deviation 0.96 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 4 | -0.3 score on a scale | Standard Deviation 0.71 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 4 | -0.3 score on a scale | Standard Deviation 0.63 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 16 | -0.5 score on a scale | Standard Deviation 0.93 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 8 | -0.3 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 8 | -0.4 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 40 | -0.1 score on a scale | Standard Deviation 0.3 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 4 | -0.3 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Baseline | 1.3 score on a scale | Standard Deviation 1.14 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 16 | -0.5 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Final Visit | -0.5 score on a scale | Standard Deviation 0.94 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 32 | -0.1 score on a scale | Standard Deviation 0.33 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 24 | -0.6 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 0.32 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 24 | -0.1 score on a scale | Standard Deviation 0.29 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 16 | -0.1 score on a scale | Standard Deviation 0.41 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 32 | -0.5 score on a scale | Standard Deviation 0.88 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Baseline | 1.2 score on a scale | Standard Deviation 0.92 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 8 | -0.1 score on a scale | Standard Deviation 0.41 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 4 | -0.1 score on a scale | Standard Deviation 0.37 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.87 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 40 | -0.6 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 4 | -0.5 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 40 | -0.1 score on a scale | Standard Deviation 0.41 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Baseline | 1.5 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 4 | -0.3 score on a scale | Standard Deviation 0.79 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 8 | -0.5 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 16 | -0.6 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 24 | -0.6 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 32 | -0.7 score on a scale | Standard Deviation 0.75 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.89 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Baseline | 0.5 score on a scale | Standard Deviation 0.71 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 4 | -0.0 score on a scale | Standard Deviation 0.66 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 8 | -0.1 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 16 | -0.0 score on a scale | Standard Deviation 0.69 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 24 | -0.2 score on a scale | Standard Deviation 0.59 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 32 | -0.2 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.66 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.67 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Baseline | 0.2 score on a scale | Standard Deviation 0.49 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 4 | -0.0 score on a scale | Standard Deviation 0.5 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 8 | -0.0 score on a scale | Standard Deviation 0.44 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 16 | -0.1 score on a scale | Standard Deviation 0.51 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 24 | -0.2 score on a scale | Standard Deviation 0.47 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 32 | -0.1 score on a scale | Standard Deviation 0.54 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 0.49 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Baseline | 1.3 score on a scale | Standard Deviation 1.14 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 8 | -0.5 score on a scale | Standard Deviation 0.77 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 16 | -0.6 score on a scale | Standard Deviation 0.85 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 24 | -0.6 score on a scale | Standard Deviation 0.85 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 32 | -0.7 score on a scale | Standard Deviation 0.94 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.82 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 0.91 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Baseline | 0.1 score on a scale | Standard Deviation 0.33 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.71 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Baseline | 1.2 score on a scale | Standard Deviation 1.08 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 8 | -0.3 score on a scale | Standard Deviation 0.63 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 8 | -0.4 score on a scale | Standard Deviation 0.65 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 4 | -0.2 score on a scale | Standard Deviation 0.66 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 16 | -0.0 score on a scale | Standard Deviation 0.28 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 40 | -0.4 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 8 | -0.3 score on a scale | Standard Deviation 0.63 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 16 | -0.4 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 4 | -0.2 score on a scale | Standard Deviation 0.6 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 24 | -0.3 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 32 | -0.4 score on a scale | Standard Deviation 0.78 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 4 | -0.3 score on a scale | Standard Deviation 0.62 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 24 | -0.0 score on a scale | Standard Deviation 0.28 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Baseline | 0.5 score on a scale | Standard Deviation 0.7 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 4 | -0.0 score on a scale | Standard Deviation 0.25 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 16 | -0.1 score on a scale | Standard Deviation 0.7 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 24 | -0.4 score on a scale | Standard Deviation 0.86 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 32 | -0.3 score on a scale | Standard Deviation 0.68 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 16 | -0.4 score on a scale | Standard Deviation 0.83 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 24 | -0.2 score on a scale | Standard Deviation 0.72 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 32 | -0.0 score on a scale | Standard Deviation 0.29 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Final Visit | -0.3 score on a scale | Standard Deviation 0.76 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Baseline | 1.2 score on a scale | Standard Deviation 0.87 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 40 | 0.0 score on a scale | Standard Deviation 0.37 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 8 | 0.0 score on a scale | Standard Deviation 0.35 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 32 | -0.2 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.71 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Final Visit | 0.0 score on a scale | Standard Deviation 0.4 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 4 | -0.2 score on a scale | Standard Deviation 0.61 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Final Visit | -0.0 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Baseline | 0.1 score on a scale | Standard Deviation 0.43 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 32 | -0.4 score on a scale | Standard Deviation 0.95 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 24 | -0.6 score on a scale | Standard Deviation 1.01 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 4 | -0.1 score on a scale | Standard Deviation 0.33 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 8 | -0.0 score on a scale | Standard Deviation 0.2 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 24 | -0.3 score on a scale | Standard Deviation 0.85 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Final Visit | -0.6 score on a scale | Standard Deviation 1.15 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 16 | 0.0 score on a scale | Standard Deviation 0.14 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 24 | 0.0 score on a scale | Standard Deviation 0.21 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 16 | -0.3 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 32 | -0.6 score on a scale | Standard Deviation 0.93 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 32 | 0.0 score on a scale | Standard Deviation 0.22 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Week 40 | 0.0 score on a scale | Standard Deviation 0.27 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dysuria-Change From Baseline to Final Visit | 0.0 score on a scale | Standard Deviation 0.28 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 8 | -0.4 score on a scale | Standard Deviation 0.64 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Baseline | 1.6 score on a scale | Standard Deviation 1.24 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 4 | -0.5 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 8 | -0.5 score on a scale | Standard Deviation 1.13 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 4 | -0.0 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Baseline | 0.5 score on a scale | Standard Deviation 0.67 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 8 | 0.0 score on a scale | Standard Deviation 0.68 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 40 | -0.7 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 16 | 0.1 score on a scale | Standard Deviation 0.47 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Final Visit | -0.5 score on a scale | Standard Deviation 0.9 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 24 | 0.0 score on a scale | Standard Deviation 0.58 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Dyspareunia-Change From Baseline to Week 16 | -0.5 score on a scale | Standard Deviation 0.88 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 32 | -0.1 score on a scale | Standard Deviation 0.59 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Change From Baseline to Week 40 | -0.5 score on a scale | Standard Deviation 0.94 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Dryness-Baseline | 1.5 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints | Vaginal Itching-Change From Baseline to Week 40 | -0.0 score on a scale | Standard Deviation 0.47 |
Secondary
Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells
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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.
Time frame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Baseline | 9.7 percentage of parabasal cells | Standard Deviation 24.34 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Final Visit | -0.4 percentage of parabasal cells | Standard Deviation 22.3 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Week 40 | 0.0 percentage of parabasal cells | Standard Deviation 20.78 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Week 40 | -42.2 percentage of parabasal cells | Standard Deviation 42 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Baseline | 42.2 percentage of parabasal cells | Standard Deviation 41.46 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Final Visit | -36.3 percentage of parabasal cells | Standard Deviation 43.18 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Week 40 | -1.5 percentage of parabasal cells | Standard Deviation 33.28 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Baseline | 12.0 percentage of parabasal cells | Standard Deviation 29.28 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Final Visit | 1.2 percentage of parabasal cells | Standard Deviation 34.67 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Baseline | 34.2 percentage of parabasal cells | Standard Deviation 38.74 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Final Visit | -24.0 percentage of parabasal cells | Standard Deviation 36.8 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells | Change From Baseline to Week 40 | -21.2 percentage of parabasal cells | Standard Deviation 36.83 |
Secondary
Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells
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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.
Time frame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Final Visit | 11.0 percentage of superficial cells | Standard Deviation 20.98 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Week 40 | 12.8 percentage of superficial cells | Standard Deviation 21.26 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Baseline | 10.4 percentage of superficial cells | Standard Deviation 11.73 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Week 40 | 17.6 percentage of superficial cells | Standard Deviation 18.21 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Baseline | 4.0 percentage of superficial cells | Standard Deviation 7.72 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Final Visit | 15.9 percentage of superficial cells | Standard Deviation 17.59 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Baseline | 16.1 percentage of superficial cells | Standard Deviation 18.77 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Week 40 | 0.5 percentage of superficial cells | Standard Deviation 20.69 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Final Visit | -0.2 percentage of superficial cells | Standard Deviation 21.79 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Week 40 | 13.9 percentage of superficial cells | Standard Deviation 24.56 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Change From Baseline to Final Visit | 13.0 percentage of superficial cells | Standard Deviation 23.02 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells | Baseline | 3.1 percentage of superficial cells | Standard Deviation 7.99 |
Secondary
Change From Baseline in Vaginal pH
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from 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. Participants at Final visit/Visit 7 included those who were to complete all the evaluations in the study including who prematurely withdrew from the study.
Time frame: Baseline (Baseline/Visit 1 for this study was the same as Final Visit/Visit 5 for completers of PR-04409.3) to Week 40 and Final Visit (Day closest to Day 281)
Population: All participants who received at least 1 dose of study drug in Study PR-04509. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal pH | Change From Baseline to Final Visit | -0.2 score on a scale | Standard Deviation 1.04 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal pH | Baseline | 5.5 score on a scale | Standard Deviation 0.81 |
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Change From Baseline in Vaginal pH | Change From Baseline to Week 40 | -0.3 score on a scale | Standard Deviation 0.97 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal pH | Change From Baseline to Week 40 | -1.0 score on a scale | Standard Deviation 1.24 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal pH | Baseline | 6.2 score on a scale | Standard Deviation 1.06 |
| WC3011 Estradiol Vaginal Cream: 92-182 Days | Change From Baseline in Vaginal pH | Change From Baseline to Final Visit | -1.0 score on a scale | Standard Deviation 1.19 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal pH | Change From Baseline to Week 40 | -0.2 score on a scale | Standard Deviation 1.04 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal pH | Baseline | 5.4 score on a scale | Standard Deviation 0.8 |
| WC3011 Estradiol Vaginal Cream: 183-273 Days | Change From Baseline in Vaginal pH | Change From Baseline to Final Visit | -0.1 score on a scale | Standard Deviation 1.08 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal pH | Baseline | 6.1 score on a scale | Standard Deviation 0.99 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal pH | Change From Baseline to Final Visit | -1.0 score on a scale | Standard Deviation 1.04 |
| WC3011 Estradiol Vaginal Cream: More Than 273 Days | Change From Baseline in Vaginal pH | Change From Baseline to Week 40 | -0.8 score on a scale | Standard Deviation 0.95 |
Secondary
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. TEAE are defined as those AEs with onset date on or after the first dose date of study drug in Study PR-04509, or adverse events that worsen after the first dose date of study drug in Study PR-04509.
Time frame: Up to Week 40
Population: All participants who received at least 1 dose of study drug in Study PR-04509.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WC3011 Estradiol Vaginal Cream: Less Than 92 Days | Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | 195 Participants |