A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
NCT ID: NCT00361569
Last Updated: 2015-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
622 participants
INTERVENTIONAL
2006-08-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
DR-2041a
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
2
DR-2041b
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
3
Placebo
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
4
Placebo
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Interventions
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DR-2041a
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
DR-2041b
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Placebo
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
Placebo
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Exclusion Criteria
* History or current diagnosis endometrial hyperplasia
* Recent history of vaginal bleeding of unknown cause
* Recent history or diagnosis of endometriosis
* Any contraindication to estrogen therapy
30 Years
80 Years
FEMALE
No
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Duramed Research, Inc.
Principal Investigators
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Duramed Protocol Chair
Role: STUDY_CHAIR
Duramed Research, Inc.
Locations
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Duramed Investigational Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Carmichael, California, United States
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Fresno, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Ramon, California, United States
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Colorado Springs, Colorado, United States
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Pueblo, Colorado, United States
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New London, Connecticut, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Pinellas Park, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Decatur, Georgia, United States
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Douglasville, Georgia, United States
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Sandy Springs, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Madisonville, Kentucky, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Livonia, Michigan, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Lawrenceville, New Jersey, United States
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Moorestown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Johnson City, New York, United States
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Williamsville, New York, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Jamestown, North Dakota, United States
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Minot, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Mayfield Heights, Ohio, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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King of Prussia, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Rosemont, Pennsylvania, United States
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Strafford, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Watertown, South Dakota, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Williston, Vermont, United States
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Newport News, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Countries
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References
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Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.
Other Identifiers
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DR-CEN-302
Identifier Type: -
Identifier Source: org_study_id
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