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.

Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

Vulvovaginal Atrophy

WC3011 Estradiol Vaginal Cream

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

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.

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.

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.

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.

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.

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.

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.

WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.

Medical Affiliated Research Center, Inc.

Warner Chilcott Investigational Site

Women's Health Research

Precision Trials, LLC

Radiant Research-Scottsdale

Radiant Research-Tucson

Visions Clinical Research-Tucson

Genesis Center for Clinical Research

Medical Center for Clinical Research

Women's Healthcare Inc.

Coastal Connecticut Research, LLC

Visions Clinical Research

Women's Medical Research Group, LLC

Jacksonville Center for Clinical Research

Miami Research Associates

New Age Medical Research Corp

Ormond Medical Arts Pharmaceutical Research Center

OB-GYN Specialists of the Palm Beaches

Radiant Research-St. Petersburg

Comprehensive Clinical Trials, LLC

Radiant Research-Atlanta

Fellows Research Alliance, Inc.

Radiant Research-Chicago

Springfield Clinical, LLP

The South Bend Clinic, LLP

Radiant Research - Overland Park

Heartland Research Associates

Bluegrass Clinical Research, Inc.

York Clinical Consulting

Women Under Study

Beyer Research

Ridgeview Research

Affiliated Clinical Research

Office of R. Garn Mabey, M.D.

Lawrence OB-GYN Associates, P.C.

Phoenix OB-GYN Assoc., LLC

Women's Health Research Center

Hawthorne Medical Research, Inc.

Eastern Carolina Women's Center

Wake Research Associates, LLC

Lyndhurst Clinical Research

Rapid Medical Research, Inc.

The Columbus Center for Women's Health Research

Clinical Trials of America, Inc.

Advanced Clinical Research

Philadelphia Clinical Research, LLC

Clinical Trials Research Services, LLC

Susan L. Floyd, MD, PC

Omega Medical Research

Practice Research Organization, Inc.

Radiant Research-Dallas

Research Across America

Advances In Health, Inc

Radiant Research-San Antonio

Center for Reproductive Medicine

J. Lewis Research-Foothill Family Clinic

J. Lewis Research - Foothill Family Clinic South

Physicians' Research Options LLC

Eastern Virginia Medical School

Virginia Women's Center

Seattle Women's: Health, Research, Gynecology

North Spokane Women's Clinic

All participants who received at least 1 dose of study drug in Study PR-04509.

WC3011 estradiol vaginal cream applied vaginally 3 times a week for up to 40 weeks.

Age, Continuous

Sex: Female, Male

Therapeutic Area, Head

Normal Biopsy: Atrophic

Normal Biopsy: Proliferative

Normal Biopsy: Unsatisfactory With Endometrial Thickness ≤4 mm

Normal Biopsy: Missing Biopsy With Endometrial Thickness ≤4 mm

Abnormal Biopsy: Polyp

Unknown: Unsatisfactory With Endometrial Thickness >4 mm

Unknown: Missing Biopsy With Endometrial Thickness >4 mm

Unknown: Unsatisfactory Without TVU Result

Unknown: Missing Biopsy Without TVU Result

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.

WC3011 estradiol vaginal cream applied vaginally 3 times a week for a median exposure of less than 92 days.

WC3011 Estradiol Vaginal Cream: Less Than 92 Days

WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of 92 to 182 days.

WC3011 Estradiol Vaginal Cream: 92-182 Days

WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of 183 to 273 days.

WC3011 Estradiol Vaginal Cream: 183-273 Days

WC3011 estradiol vaginal cream applied vaginally 3 times a week for median exposure of more than 273 days.

WC3011 Estradiol Vaginal Cream: More Than 273 Days

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.

Number of Participants With Endometrial Biopsy Results at Final Visit

Vaginal Dryness-Baseline

Vaginal Dryness-Change From Baseline to Week 4

Vaginal Dryness-Change From Baseline to Week 8

Vaginal Dryness-Change From Baseline to Week 16

Vaginal Dryness-Change From Baseline to Week 24

Vaginal Dryness-Change From Baseline to Week 32

Vaginal Dryness-Change From Baseline to Week 40

Vaginal Dryness-Change From Baseline to Final Visit

Vaginal Itching-Baseline

Vaginal Itching-Change From Baseline to Week 4

Vaginal Itching-Change From Baseline to Week 8

Vaginal Itching-Change From Baseline to Week 16

Vaginal Itching-Change From Baseline to Week 24

Vaginal Itching-Change From Baseline to Week 32

Vaginal Itching-Change From Baseline to Week 40

Vaginal Itching-Change From Baseline to Final Visit

Dysuria-Baseline

Dysuria-Change From Baseline to Week 4

Dysuria-Change From Baseline to Week 8

Dysuria-Change From Baseline to Week 16

Dysuria-Change From Baseline to Week 24

Dysuria-Change From Baseline to Week 32

Dysuria-Change From Baseline to Week 40

Dysuria-Change From Baseline to Final Visit

Dyspareunia-Baseline

Dyspareunia-Change From Baseline to Week 4

Dyspareunia-Change From Baseline to Week 8

Dyspareunia-Change From Baseline to Week 16

Dyspareunia-Change From Baseline to Week 24

Dyspareunia-Change From Baseline to Week 32

Dyspareunia-Change From Baseline to Week 40

Dyspareunia-Change From Baseline to Final Visit

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).

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 vehicle 2 times a week in the previous study were included in this arm group).

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 WC13011 estradiol vaginal cream 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 vehicle 3 times a week in the previous study were included in this arm group).

Previous Vehicle (3 Times/Week)

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.

Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints

Baseline

Change From Baseline to Week 40

Change From Baseline to Final Visit

Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells

Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells

Change From Baseline in Vaginal pH

Atrophy-Baseline

Atrophy-Change From Baseline to Week 40

Atrophy-Change From Baseline to Final Visit

Pallor-Baseline

Pallor-Change From Baseline to Week 40

Pallor-Change From Baseline to Final Visit

Dryness-Baseline

Dryness-Change From Baseline to Week 40

Dryness-Change From Baseline to Final Visit

Friability-Baseline

Friability-Change From Baseline to Week 40

Friability-Change From Baseline to Final Visit

Petechiae-Baseline

Petechiae-Change From Baseline at Week 40

Petechiae-Change From Baseline to Final Visit

Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)

Overall Study

Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?