| Primary | Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment | Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment. | Modified Intent-to-Treat (mITT) Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 0) to final assessment (Up to Week 12) | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG000240
- ParticipantsOG001248
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| Primary | Change From Baseline in Vaginal pH to Final Assessment | Vaginal pH was obtained at baseline and 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. Final assessment is defined as the last available postbaseline assessment. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 0) to final assessment (Up to Week 12) | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Primary | Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment | 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. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | percentage of superficial cells | | Baseline (Day 0) to final assessment (Up to Week 12) | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Primary | Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment | 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. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | percentage of parabasal cells | | Baseline (Day 0) to final assessment (Up to Week 12) | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| 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 Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 0) to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Secondary | Change From Baseline in Participants Self-Assessment of the Symptoms of VVA | Self-Assessment of the symptoms of VVA (vaginal and/or vulvar irritation/ Itching, dysuria, and dyspareunia) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Secondary | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity | Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final assessment is defined as the last available postbaseline assessment. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Number | | percentage of participants | | Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Secondary | Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment | 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 each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 0) to Week 12 and Final Assessment | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Secondary | Change From Baseline in the 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. A positive change from Baseline indicates improvement. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | percentage of superficial cells | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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| Secondary | Change From Baseline in the 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. A negative change from Baseline indicates improvement. | mITT Population included participants in safety population who had at least 1 postbaseline primary efficacy assessment and had: ≤5% superficial cells on a vaginal wall smear, a vaginal pH >5.0 and participant's most bothersome symptom of VVA was vaginal dryness with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | Posted | | Mean | Standard Deviation | percentage of parabasal cells | | Baseline (Day 0) to Week 12 | | | | ID | Title | Description |
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| OG000 | Vehicle (2 Times/Week) | Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks. | | OG001 | 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. |
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