Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
- Conditions
- Vulvovaginal Atrophy
- Interventions
- Drug: WC3011 Estradiol Vaginal Cream
- Registration Number
- NCT01455597
- Lead Sponsor
- Warner Chilcott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 309
- Completed Study PR-04409.3 (NCT01400776)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WC3011 Estradiol Vaginal Cream WC3011 Estradiol Vaginal Cream WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Endometrial Biopsy Results at Final Visit Final Visit (Day closest to Day 281) 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
Name Time Method Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints 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) 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 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) 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 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) 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 as Per Investigator's Assessment of Each of the Signs of VVA 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) 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.
Change From Baseline in Vaginal pH 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) 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.
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) Up to Week 40 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.
Trial Locations
- Locations (62)
Warner Chilcott Investigational Site
🇺🇸Mobile, Alabama, United States
Radiant Research-Dallas
🇺🇸Dallas, Texas, United States
Advances In Health, Inc
🇺🇸Houston, Texas, United States
Seattle Women's: Health, Research, Gynecology
🇺🇸Seattle, Washington, 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
Affiliated Clinical Research
🇺🇸Las Vegas, Nevada, United States
Office of R. Garn Mabey, M.D.
🇺🇸Las Vegas, Nevada, United States
Radiant Research - Overland Park
🇺🇸Overland Park, Kansas, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Radiant Research-San Antonio
🇺🇸San Antonio, Texas, United States
J. Lewis Research - Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Advanced Clinical Research
🇺🇸Medford, Oregon, United States
Ridgeview Research
🇺🇸Chaska, Minnesota, United States
Radiant Research-St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
New Age Medical Research Corp
🇺🇸Miami, Florida, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Radiant Research-Chicago
🇺🇸Chicago, Illinois, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Fellows Research Alliance, Inc.
🇺🇸Bluffton, South Carolina, United States
Women's Health Research Center
🇺🇸Plainsboro, New Jersey, United States
Springfield Clinical, LLP
🇺🇸Springfield, Illinois, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
The Columbus Center for Women's Health Research
🇺🇸Columbus, Ohio, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Hawthorne Medical Research, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
OB-GYN Specialists of the Palm Beaches
🇺🇸Palm Beach Gardens, Florida, United States
The South Bend Clinic, LLP
🇺🇸Granger, Indiana, United States
York Clinical Consulting
🇺🇸Marrero, Louisiana, United States
Radiant Research-Atlanta
🇺🇸Atlanta, Georgia, United States
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Susan L. Floyd, MD, PC
🇺🇸Wexford, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Philadelphia Clinical Research, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Practice Research Organization, Inc.
🇺🇸Dallas, Texas, United States
Center for Reproductive Medicine
🇺🇸Webster, Texas, United States
Research Across America
🇺🇸Dallas, Texas, United States
J. Lewis Research-Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Physicians' Research Options LLC
🇺🇸Sandy, Utah, United States
Virginia Women's Center
🇺🇸Richmond, Virginia, United States
North Spokane Women's Clinic
🇺🇸Spokane, Washington, United States
Phoenix OB-GYN Assoc., LLC
🇺🇸Moorestown, New Jersey, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Lawrence OB-GYN Associates, P.C.
🇺🇸Lawrenceville, New Jersey, United States
Precision Trials, LLC
🇺🇸Phoenix, Arizona, United States
Radiant Research-Tucson
🇺🇸Tucson, Arizona, United States
Radiant Research-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Women Under Study
🇺🇸New Orleans, Louisiana, United States
Visions Clinical Research-Tucson
🇺🇸Tucson, Arizona, United States