Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
NCT ID: NCT01455597
Last Updated: 2022-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2011-10-20
2012-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Interventions
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WC3011 Estradiol Vaginal Cream
WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Chan, PharmD
Role: STUDY_DIRECTOR
Allergan
Locations
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Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Warner Chilcott Investigational Site
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
Coastal Connecticut Research, 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 Beaches
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
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
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
Chaska, Minnesota, 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
Phoenix OB-GYN Assoc., LLC
Moorestown, New Jersey, United States
Women's Health Research Center
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
Clinical Trials of America, Inc.
Eugene, Oregon, United States
Advanced Clinical Research
Medford, Oregon, 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
Practice Research Organization, Inc.
Dallas, Texas, United States
Radiant Research-Dallas
Dallas, Texas, United States
Research Across America
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
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Other Identifiers
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PR-04509
Identifier Type: -
Identifier Source: org_study_id
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