Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
NCT ID: NCT01400776
Last Updated: 2022-05-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
722 participants
INTERVENTIONAL
2011-06-29
2012-02-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
NCT01455597
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
NCT01845649
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
NCT01816139
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
NCT02670785
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
NCT02253173
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WC3011 Estradiol Vaginal Cream (2 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
Vehicle (2 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Vehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
WC3011 Estradiol Vaginal Cream (3 Times/Week)
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
Vehicle (3 Times/Week)
Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Vehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
Vehicle
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
* Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks
* Insulin-dependent diabetes mellitus
* Increased frequency or severity of headaches while on hormone or estrogen therapy
* Drug or alcohol addiction within last 2 years
* Participation in a clinical trial within 30 days
* Smoking ≥ 15 cigarettes daily
* Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Warner Chilcott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anna Chan, PharmD
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Mobile OB-GYN, PC
Mobile, Alabama, United States
Women's Health Research
Phoenix, Arizona, United States
Precision Trials, LLC
Phoenix, Arizona, United States
Radiant Research-Scottsdale
Scottsdale, Arizona, United States
Radiant Research-Tucson
Tucson, Arizona, United States
Visions Clinical Research-tucson
Tucson, Arizona, 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
Lakewood, Colorado, United States
Costal Connecticut Resarch, LLC
New London, Connecticut, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Miami Research Associates
Miami, Florida, United States
New Age Medical Research Corp
Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
OB-GYN Specialists of the Palm
Palm Beach Gardens, Florida, United States
Radiant Research-St. Petersburg
Pinellas Park, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Radiant Research-Atlanta
Atlanta, Georgia, United States
Soapstone Center for Clinical Research
Decatur, Georgia, United States
Atlanta North Gynecology, PC
Roswell, Georgia, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, United States
Radiant Research-Chicago
Chicago, Illinois, United States
Springfield Clinical, LLP
Springfield, Illinois, United States
The South Bend Clinic, LLP
Granger, Indiana, United States
Radiant Research - Overland Park
Overland Park, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Kentucky Pediatric Research, Inc.
Bardstown, Kentucky, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
York Clinical Consulting
Marrero, Louisiana, United States
Women Under Study
New Orleans, Louisiana, United States
Beyer Research
Kalamazoo, Michigan, United States
Ridgeview Research Two Twelve Medical Center
Chaska, Minnesota, United States
Affiliated Clinical Research
Las Vegas, Nevada, United States
Lawrence OB-GYN Associates, P.C.
Lawrenceville, New Jersey, United States
Phoenix OB-GYN Assoc., LLC
Moorestown, New Jersey, United States
The Center for Women's Health and Wellness, LLC
Plainsboro, New Jersey, United States
Hawthorne Medical Research, Inc.
Greensboro, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
The Columbus Center for Women's Health Research
Columbus, Ohio, United States
HWC - Women's Research Center
Englewood, Ohio, United States
Clinical Trials of America, Inc.
Eugene, Oregon, United States
Advanced Clinical Research
Medford, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Susan L. Floyd, MD, PC
Wexford, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Fellows Research Alliance, Inc.
Bluffton, South Carolina, United States
SC Clinical Research Center, LLC
Columbia, South Carolina, United States
Practice Research Organization, Inc.
Dallas, Texas, United States
Radiant Research-Dallas
Dallas, Texas, United States
Research Across America RHD Professional Plaza 4
Dallas, Texas, United States
Advances in Health, Inc.
Houston, Texas, United States
Radiant Research-San Antonio
San Antonio, Texas, United States
Center for Reproductive Medicine
Webster, Texas, United States
J. Lewis Research-foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research - Foothill Family Clinic South
Salt Lake City, Utah, United States
Physicians' Research Options LLC
Sandy City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Women's Center
Richmond, Virginia, United States
Seattle Women's: Health, Research Gynecology
Seattle, Washington, United States
North Spokane Women's Clinic
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR-04409.3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.