DHEA Against Vaginal Atrophy - Safety Study of 12 Months



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:40 - 75
Updated:10/20/2017
Start Date:December 2010
End Date:December 2012

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The purpose of this Phase III trial is to assess the long-term safety of intravaginal
dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal
atrophy aged 40 to 75 years.


Main Inclusion Criteria:

- Postmenopausal women (non-hysterectomized)

- Women between 40 and 75 years of age.

- Willing to participate in the study and sign an informed consent.

- Women who have self-identified symptom(s) of vaginal atrophy.

- Willing to have endometrial biopsy at screening and end of study (Week 52).

Main Exclusion Criteria:

- Undiagnosed abnormal genital bleeding.

- Hypertension equal to or above 140/90 mm Hg.

- The administration of any investigational drug within 30 days of screening visit.

- Endometrial hyperplasia, cancer or endometrial histology showing proliferative,
secretory or menstrual type characteristics at histologic evaluation of endometrial
biopsy performed at screening.
We found this trial at
30
sites
Milford, Connecticut 06460
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Milford, CT
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Baltimore, Maryland 21285
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Baltimore, MD
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Beachwood, Ohio 44122
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Beachwood, OH
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Boynton Beach, Florida 33472
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Boynton Beach, FL
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Calgary, Alberta
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Calgary,
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Charlottesville, Virginia 22903
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Charlottesville, VA
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Cleveland, Ohio 44122
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Cleveland, OH
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Columbus, Ohio 43213
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Columbus, OH
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Denver, Colorado 80209
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Denver, CO
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Durham, North Carolina 27713
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Durham, NC
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Lincoln, Nebraska 68510
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Lincoln, NE
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Meridian, Idaho 83642
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Meridian, ID
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Montgomery, Alabama 36117
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Montgomery, AL
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Moorestown, New Jersey 08057
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Moorestown, NJ
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Neptune City, New Jersey 07753
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Neptune City, NJ
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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New York, New York 10016
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New York, NY
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Norfolk, Virginia 23507
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Norfolk, VA
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Omaha, Nebraska 68131
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Omaha, NE
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Pittsburgh, Pennsylvania 15206
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Pittsburgh, PA
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Renton, Washington 98055
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Renton, WA
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Sacramento, California 95821
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Sacramento, CA
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San Diego, California 92120
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San Diego, CA
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Sandy Springs, Georgia 30328
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Sandy Springs, GA
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Tucson, Arizona 85712
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Tucson, AZ
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Washington, D.C., District of Columbia 20036
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Washington, D.C.,
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West Jordan, Utah 84088
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West Jordan, UT
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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