Back to resultsEvaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
WC3011 Estradiol Vaginal Cream
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Postmenopausal Women, Vaginal Dryness, Postmenopausal Vulvovaginal Atrophy
Eligibility Criteria
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
Sites / Locations
- 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
- Hawthorne Medical Research, Inc.
- 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
- Fellows Research Alliance, Inc.
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WC3011 Estradiol Vaginal Cream
Arm Description
WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01455597
Brief Title
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2011 (Actual)
Primary Completion Date
December 3, 2012 (Actual)
Study Completion Date
December 3, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Postmenopausal Women, Vaginal Dryness, Postmenopausal Vulvovaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WC3011 Estradiol Vaginal Cream
Arm Type
Experimental
Arm Description
WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
Intervention Type
Drug
Intervention Name(s)
WC3011 Estradiol Vaginal Cream
Intervention Description
WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Endometrial Biopsy Results at Final Visit
Description
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.
Time Frame
Final Visit (Day closest to Day 281)
Secondary Outcome Measure Information:
Title
Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints
Description
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.
Time Frame
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)
Title
Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells
Description
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.
Time Frame
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)
Title
Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells
Description
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.
Time Frame
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)
Title
Change From Baseline in Vaginal pH
Description
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.
Time Frame
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)
Title
Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA
Description
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.
Time Frame
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)
Title
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
Description
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.
Time Frame
Up to Week 40
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study was to treat the symptoms of vulvovaginal atrophy in postmenopausal women.
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan, PharmD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Precision Trials, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Radiant Research-Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Radiant Research-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Visions Clinical Research-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Healthcare Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
New Age Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
OB-GYN Specialists of the Palm Beaches
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Radiant Research-St. Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Radiant Research-Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Radiant Research-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Springfield Clinical, LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
The South Bend Clinic, LLP
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
Radiant Research - Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
York Clinical Consulting
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Women Under Study
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Ridgeview Research
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Affiliated Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Office of R. Garn Mabey, M.D.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lawrence OB-GYN Associates, P.C.
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Phoenix OB-GYN Assoc., LLC
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Eastern Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
The Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Advanced Clinical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Susan L. Floyd, MD, PC
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Practice Research Organization, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Radiant Research-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Advances In Health, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Radiant Research-San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Reproductive Medicine
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
J. Lewis Research-Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research - Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Physicians' Research Options LLC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
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