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

Vulvovaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455597
• Other study ID #: PR-04509
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2011
• Est. completion date: December 3, 2012

Study information

• Verified date: September 2021
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: December 3, 2012
• Est. primary completion date: December 3, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Drug:
• WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.

Locations

Country	Name	City	State
United States	Radiant Research-Atlanta	Atlanta	Georgia
United States	Fellows Research Alliance, Inc.	Bluffton	South Carolina
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Ridgeview Research	Chaska	Minnesota
United States	Radiant Research-Chicago	Chicago	Illinois
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	The Columbus Center for Women's Health Research	Columbus	Ohio
United States	Practice Research Organization, Inc.	Dallas	Texas
United States	Radiant Research-Dallas	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Clinical Trials of America, Inc.	Eugene	Oregon
United States	The South Bend Clinic, LLP	Granger	Indiana
United States	Hawthorne Medical Research, Inc.	Greensboro	North Carolina
United States	Advances In Health, Inc	Houston	Texas
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Beyer Research	Kalamazoo	Michigan
United States	Affiliated Clinical Research	Las Vegas	Nevada
United States	Office of R. Garn Mabey, M.D.	Las Vegas	Nevada
United States	Lawrence OB-GYN Associates, P.C.	Lawrenceville	New Jersey
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	York Clinical Consulting	Marrero	Louisiana
United States	Advanced Clinical Research	Medford	Oregon
United States	Miami Research Associates	Miami	Florida
United States	New Age Medical Research Corp	Miami	Florida
United States	Warner Chilcott Investigational Site	Mobile	Alabama
United States	Phoenix OB-GYN Assoc., LLC	Moorestown	New Jersey
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Women Under Study	New Orleans	Louisiana
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	Radiant Research - Overland Park	Overland Park	Kansas
United States	OB-GYN Specialists of the Palm Beaches	Palm Beach Gardens	Florida
United States	Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania
United States	Precision Trials, LLC	Phoenix	Arizona
United States	Women's Health Research	Phoenix	Arizona
United States	Radiant Research-St. Petersburg	Pinellas Park	Florida
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Women's Health Research Center	Plainsboro	New Jersey
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Virginia Women's Center	Richmond	Virginia
United States	J. Lewis Research - Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research-Foothill Family Clinic	Salt Lake City	Utah
United States	Radiant Research-San Antonio	San Antonio	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Women's Healthcare Inc.	San Diego	California
United States	Physicians' Research Options LLC	Sandy	Utah
United States	Fellows Research Alliance, Inc.	Savannah	Georgia
United States	Radiant Research-Scottsdale	Scottsdale	Arizona
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	North Spokane Women's Clinic	Spokane	Washington
United States	Springfield Clinical, LLP	Springfield	Illinois
United States	Radiant Research-Tucson	Tucson	Arizona
United States	Visions Clinical Research-Tucson	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Center for Reproductive Medicine	Webster	Texas
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Susan L. Floyd, MD, PC	Wexford	Pennsylvania
United States	Heartland Research Associates	Wichita	Kansas
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Final Visit (Day closest to Day 281)
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.	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.	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.	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.	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.	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.	Up to Week 40