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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WC3011 Estradiol Vaginal Cream | Experimental | WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WC3011 Estradiol Vaginal Cream | Drug | WC3011 estradiol vaginal cream, 3 times a week for 40 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Final Visit (Day closest to Day 281) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:
The study was to treat the symptoms of vulvovaginal atrophy in postmenopausal women.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chan, PharmD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | United States | ||
| Warner Chilcott Investigational Site |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Previous WC3011 Estradiol Vaginal Cream (2 Times/Week) | WC3011 estradiol vaginal cream. applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC3011 estradiol vaginal cream 2 times a week in the previous study were included in this arm group). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | Up to Week 40 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Women's Health Research | Phoenix | Arizona | 85015 | United States |
| Precision Trials, LLC | Phoenix | Arizona | 85032 | United States |
| Radiant Research-Scottsdale | Scottsdale | Arizona | 85251 | United States |
| Radiant Research-Tucson | Tucson | Arizona | 85710 | United States |
| Visions Clinical Research-Tucson | Tucson | Arizona | 85712 | United States |
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Women's Healthcare Inc. | San Diego | California | 92123 | United States |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| New Age Medical Research Corp | Miami | Florida | 33186 | United States |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | United States |
| OB-GYN Specialists of the Palm Beaches | Palm Beach Gardens | Florida | 33410 | United States |
| Radiant Research-St. Petersburg | Pinellas Park | Florida | 33781 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Radiant Research-Atlanta | Atlanta | Georgia | 30342 | United States |
| Fellows Research Alliance, Inc. | Savannah | Georgia | 31406 | United States |
| Radiant Research-Chicago | Chicago | Illinois | 60654 | United States |
| Springfield Clinical, LLP | Springfield | Illinois | 62703 | United States |
| The South Bend Clinic, LLP | Granger | Indiana | 46530 | United States |
| Radiant Research - Overland Park | Overland Park | Kansas | 66202 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | United States |
| York Clinical Consulting | Marrero | Louisiana | 70072 | United States |
| Women Under Study | New Orleans | Louisiana | 70115 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Ridgeview Research | Chaska | Minnesota | 55318 | United States |
| Affiliated Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Office of R. Garn Mabey, M.D. | Las Vegas | Nevada | 89128 | United States |
| Lawrence OB-GYN Associates, P.C. | Lawrenceville | New Jersey | 08648 | United States |
| Phoenix OB-GYN Assoc., LLC | Moorestown | New Jersey | 08057 | United States |
| Women's Health Research Center | Plainsboro | New Jersey | 08536 | United States |
| Hawthorne Medical Research, Inc. | Greensboro | North Carolina | 27408 | United States |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| The Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | United States |
| Clinical Trials of America, Inc. | Eugene | Oregon | 97401 | United States |
| Advanced Clinical Research | Medford | Oregon | 97504 | United States |
| Philadelphia Clinical Research, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | United States |
| Susan L. Floyd, MD, PC | Wexford | Pennsylvania | 15090 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Fellows Research Alliance, Inc. | Bluffton | South Carolina | 29910 | United States |
| Practice Research Organization, Inc. | Dallas | Texas | 75230 | United States |
| Radiant Research-Dallas | Dallas | Texas | 75231 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Advances In Health, Inc | Houston | Texas | 77030 | United States |
| Radiant Research-San Antonio | San Antonio | Texas | 78229 | United States |
| Center for Reproductive Medicine | Webster | Texas | 77598 | United States |
| J. Lewis Research-Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research - Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Physicians' Research Options LLC | Sandy City | Utah | 84070 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507-1627 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| North Spokane Women's Clinic | Spokane | Washington | 99207 | United States |
| Previous Vehicle (2 Times/Week) |
WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 2 times a week in the previous study were included in this arm group). |
| FG002 | Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| FG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
| All-Participants-Treated Population | All enrolled participants who received at least 1 dose of study drug in Study PR-04509. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug in Study PR-04509.
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| ID | Title | Description |
|---|---|---|
| BG000 | WC3011 Estradiol Vaginal Cream | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Final Visit (Day closest to Day 281) |
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| |||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of superficial 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) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of parabasal 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) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
| ||||||||||||||||||||||||||||||||||||
| 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. | All participants who received at least 1 dose of study drug in Study PR-04509. | Posted | Count of Participants | Participants | Up to Week 40 |
|
|
Up to Week 40
All participants who received at least 1 dose of study drug in Study PR-04509.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WC3011 Estradiol Vaginal Cream | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks. | 0 | 308 | 8 | 308 | 50 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA: 12.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA: 12.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA: 12.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA: 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA: 12.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA: 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA: 12.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Normal Biopsy: Proliferative |
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| Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm |
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| Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm |
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| Abnormal Biopsy: Polyp |
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| Unknown: Unsatisfactory With Endometrial Thickness >4 mm |
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| Unknown: Missing Biopsy With Endometrial Thickness >4 mm |
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| Unknown: Unsatisfactory Without TVU Result |
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| Unknown: Missing Biopsy Without TVU Result |
|
| OG001 | Previous Vehicle (2 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 2 times a week in the previous study were included in this arm group). |
| OG002 | Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| OG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
|
|
| OG002 |
| Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) |
WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| OG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
|
|
| Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) |
WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| OG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
|
|
| OG002 | Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| OG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
|
|
| OG002 | Previous WC3011 Estradiol Vaginal Cream (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received WC13011 estradiol vaginal cream 3 times a week in the previous study were included in this arm group). |
| OG003 | Previous Vehicle (3 Times/Week) | WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks in this study (Participants who received vehicle 3 times a week in the previous study were included in this arm group). |
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