Trial Outcomes & Findings for Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women (NCT NCT01816139)

Last Updated: 2022-05-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

Baseline (Day 0) to final assessment (Up to Week 12)

Results posted on

2022-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Vehicle (2 Times/Week) Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	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.
Overall Study STARTED	289	287
Overall Study Safety Population	287	286
Overall Study Modified Intent-to-treat (mITT) Population	240	248
Overall Study COMPLETED	261	265
Overall Study NOT COMPLETED	28	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle (2 Times/Week) Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	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.
Overall Study Adverse Event	6	8
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	5	3
Overall Study Withdrew Consent	6	4
Overall Study Protocol Violation	6	3
Overall Study Reason not Specified	4	2

Baseline Characteristics

Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle (2 Times/Week) n=287 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=286 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	Total n=573 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 6.1 • n=5 Participants	59.5 years STANDARD_DEVIATION 6.7 • n=7 Participants	59.6 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	287 Participants n=5 Participants	286 Participants n=7 Participants	573 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment Baseline	2.5 score on a scale Standard Deviation 0.50	2.5 score on a scale Standard Deviation 0.50
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment Change from Baseline to Final Assessment	-1.2 score on a scale Standard Deviation 0.92	-1.4 score on a scale Standard Deviation 0.94

PRIMARY outcome

Timeframe: Baseline (Day 0) to final assessment (Up to Week 12)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in Vaginal pH to Final Assessment Baseline	6.33 score on a scale Standard Deviation 0.65	6.34 score on a scale Standard Deviation 0.65
Change From Baseline in Vaginal pH to Final Assessment Change from Baseline to Final Assessment	-0.31 score on a scale Standard Deviation 0.80	-1.26 score on a scale Standard Deviation 0.99

PRIMARY outcome

Timeframe: Baseline (Day 0) to final assessment (Up 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. Final assessment is defined as the last available postbaseline assessment.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment Baseline	0.3 percentage of superficial cells Standard Deviation 1.05	0.4 percentage of superficial cells Standard Deviation 1.13
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment Change from Baseline to Final Assessment	0.8 percentage of superficial cells Standard Deviation 5.68	8.6 percentage of superficial cells Standard Deviation 14.49

PRIMARY outcome

Timeframe: Baseline (Day 0) to final assessment (Up 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. Final assessment is defined as the last available postbaseline assessment.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment Baseline	46.5 percentage of parabasal cells Standard Deviation 44.81	44.2 percentage of parabasal cells Standard Deviation 42.29
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment Change from Baseline to Final Assessment	-4.4 percentage of parabasal cells Standard Deviation 42.93	-37.4 percentage of parabasal cells Standard Deviation 42.62

SECONDARY outcome

Timeframe: Baseline (Day 0) to Weeks 2, 4, 8, and 12

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 Baseline	2.5 score on a scale Standard Deviation 0.50	2.5 score on a scale Standard Deviation 0.50
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 Change from Baseline to Week 2	-0.9 score on a scale Standard Deviation 0.92	-1.0 score on a scale Standard Deviation 0.94
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 Change from Baseline to Week 4	-1.1 score on a scale Standard Deviation 0.87	-1.2 score on a scale Standard Deviation 0.86
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 Change from Baseline to Week 8	-1.2 score on a scale Standard Deviation 0.87	-1.4 score on a scale Standard Deviation 0.85
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 Change from Baseline to Week 12	-1.2 score on a scale Standard Deviation 0.90	-1.5 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment

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.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment

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.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=184 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=177 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Week 12	6.6 percentage of participants	3.8 percentage of participants
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Baseline	18.5 percentage of participants	24.3 percentage of participants
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Week 2	8.4 percentage of participants	8.4 percentage of participants
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Week 4	6.1 percentage of participants	4.6 percentage of participants
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Week 8	8.0 percentage of participants	6.7 percentage of participants
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity Final Assessment	7.9 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0) 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.

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Atrophy - Baseline	2.1 score on a scale Standard Deviation 0.60	2.0 score on a scale Standard Deviation 0.65
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Atrophy - Change from Baseline to Week 12	-0.4 score on a scale Standard Deviation 0.74	-0.7 score on a scale Standard Deviation 0.80
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Atrophy - Change from Baseline to Final Assessment	-0.4 score on a scale Standard Deviation 0.74	-0.7 score on a scale Standard Deviation 0.79
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Pallor - Baseline	1.9 score on a scale Standard Deviation 0.67	1.9 score on a scale Standard Deviation 0.66
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Pallor - Change from Baseline to Week 12	-0.4 score on a scale Standard Deviation 0.79	-0.9 score on a scale Standard Deviation 0.79
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Pallor - Change from Baseline to Final Assessment	-0.4 score on a scale Standard Deviation 0.79	-0.9 score on a scale Standard Deviation 0.82
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Dryness - Baseline	2.0 score on a scale Standard Deviation 0.65	2.0 score on a scale Standard Deviation 0.69
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Dryness - Change from Baseline to Week 12	-0.6 score on a scale Standard Deviation 0.84	-1.1 score on a scale Standard Deviation 0.89
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Dryness - Change from Baseline to Final Assessment	-0.6 score on a scale Standard Deviation 0.84	-1.1 score on a scale Standard Deviation 0.89
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Friability - Baseline	1.1 score on a scale Standard Deviation 0.86	1.1 score on a scale Standard Deviation 0.86
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Friability - Change from Baseline to Week 12	-0.5 score on a scale Standard Deviation 0.81	-0.8 score on a scale Standard Deviation 0.92
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Friability - Change from Baseline to Final Assessment	-0.5 score on a scale Standard Deviation 0.81	-0.8 score on a scale Standard Deviation 0.92
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Petechiae - Baseline	0.8 score on a scale Standard Deviation 0.86	0.8 score on a scale Standard Deviation 0.82
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Petechiae - Change from Baseline to Week 12	-0.4 score on a scale Standard Deviation 0.71	-0.6 score on a scale Standard Deviation 0.82
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment Petechiae - Change from Baseline to Final Assessment	-0.4 score on a scale Standard Deviation 0.74	-0.6 score on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 Baseline	0.3 percentage of superficial cells Standard Deviation 1.05	0.4 percentage of superficial cells Standard Deviation 1.13
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 Change from Baseline to Week 12	0.6 percentage of superficial cells Standard Deviation 3.35	9.3 percentage of superficial cells Standard Deviation 14.87

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 12

Outcome measures

Outcome measures
Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12 Baseline	46.5 percentage of parabasal cells Standard Deviation 44.81	44.2 percentage of parabasal cells Standard Deviation 42.29
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12 Change from Baseline to Week 12	-4.7 percentage of parabasal cells Standard Deviation 43.39	-38.7 percentage of parabasal cells Standard Deviation 41.58

Adverse Events

Vehicle (2 Times/Week)

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle (2 Times/Week) n=287 participants at risk Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=286 participants at risk WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Cardiac disorders Myocardial Infarction	0.00% 0/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	0.35% 1/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.
Gastrointestinal disorders Hiatus Hernia	0.00% 0/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	0.35% 1/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.
General disorders Non-Cardiac Chest Pain	0.35% 1/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	0.00% 0/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.
Infections and infestations Postoperative Wound Infection	0.35% 1/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	0.00% 0/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Vehicle (2 Times/Week) n=287 participants at risk Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=286 participants at risk WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Infections and infestations Urinary tract infection	5.9% 17/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	5.2% 15/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.
General disorders Application site pain	5.6% 16/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	3.1% 9/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.
Infections and infestations Vulvovaginal mycotic infection	1.0% 3/287 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.	5.2% 15/286 • From first dose through the last study visit (Up to 12 weeks) Safety Population included all participants who were randomized into the study and took at least 1 dose of study drug.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	Vehicle (2 Times/Week) n=240 Participants Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.	WC3011 Estradiol Vaginal Cream (2 Times/Week) n=248 Participants WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Baseline	1.1 score on a scale Standard Deviation 0.97	1.1 score on a scale Standard Deviation 0.97
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Change from Baseline to Week 2	-0.5 score on a scale Standard Deviation 0.93	-0.5 score on a scale Standard Deviation 0.95
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Change from Baseline to Week 4	-0.6 score on a scale Standard Deviation 0.99	-0.6 score on a scale Standard Deviation 0.89
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Change from Baseline to Week 8	-0.6 score on a scale Standard Deviation 0.95	-0.6 score on a scale Standard Deviation 0.92
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Change from Baseline to Week 12	-0.7 score on a scale Standard Deviation 1.00	-0.7 score on a scale Standard Deviation 0.94
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Vaginal Itching - Change from Baseline to Final Assessment	-0.7 score on a scale Standard Deviation 0.99	-0.6 score on a scale Standard Deviation 0.99
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Baseline	0.3 score on a scale Standard Deviation 0.66	0.4 score on a scale Standard Deviation 0.72
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Change from Baseline to Week 2	-0.1 score on a scale Standard Deviation 0.71	-0.2 score on a scale Standard Deviation 0.66
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Change from Baseline to Week 4	-0.1 score on a scale Standard Deviation 0.75	-0.2 score on a scale Standard Deviation 0.69
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Change from Baseline to Week 8	-0.2 score on a scale Standard Deviation 0.65	-0.2 score on a scale Standard Deviation 0.75
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Change from Baseline to Week 12	-0.2 score on a scale Standard Deviation 0.65	-0.2 score on a scale Standard Deviation 0.69
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dysuria - Change from Baseline to Final Assessment	-0.2 score on a scale Standard Deviation 0.64	-0.2 score on a scale Standard Deviation 0.71
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Baseline	2.1 score on a scale Standard Deviation 0.92	2.1 score on a scale Standard Deviation 0.99
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Change from Baseline to Week 2	-0.7 score on a scale Standard Deviation 0.91	-0.7 score on a scale Standard Deviation 1.04
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Change from Baseline to Week 4	-1.0 score on a scale Standard Deviation 0.90	-1.1 score on a scale Standard Deviation 1.05
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Change from Baseline to Week 8	-0.9 score on a scale Standard Deviation 0.99	-1.2 score on a scale Standard Deviation 1.03
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Change from Baseline to Week 12	-1.1 score on a scale Standard Deviation 0.97	-1.1 score on a scale Standard Deviation 1.12
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA Dyspareunia - Change from Baseline to Final Assessment	-1.0 score on a scale Standard Deviation 0.95	-1.1 score on a scale Standard Deviation 1.11