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
West Palm Beach, Florida 33409
1284
mi
from
West Palm Beach, FL
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Baltimore, Maryland 21285
1149
mi
from
Baltimore, MD
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Beachwood, Ohio 44122
903
mi
from
Beachwood, OH
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Boynton Beach, Florida 33472
1292
mi
from
Boynton Beach, FL
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Calgary, Alberta
1214
mi
from
Calgary,
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Charlottesville, Virginia 22903
1053
mi
from
Charlottesville, VA
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Cleveland, Ohio 44122
903
mi
from
Cleveland, OH
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Columbus, Ohio 43213
817
mi
from
Columbus, OH
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Denver, Colorado 80209
407
mi
from
Denver, CO
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Durham, North Carolina 27713
1051
mi
from
Durham, NC
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Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
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Kalamazoo, Michigan 49009
714
mi
from
Kalamazoo, MI
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Lincoln, Nebraska 68510
219
mi
from
Lincoln, NE
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Meridian, Idaho 83642
1051
mi
from
Meridian, ID
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Milford, Connecticut 06460
1337
mi
from
Milford, CT
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Montgomery, Alabama 36117
754
mi
from
Montgomery, AL
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Moorestown, New Jersey 08057
1236
mi
from
Moorestown, NJ
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Neptune City, New Jersey 07753
1285
mi
from
Neptune City, NJ
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New Brunswick, New Jersey 08901
1263
mi
from
New Brunswick, NJ
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New York, New York 10016
1288
mi
from
New York, NY
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Norfolk, Virginia 23507
1182
mi
from
Norfolk, VA
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Omaha, Nebraska 68131
262
mi
from
Omaha, NE
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Pittsburgh, Pennsylvania 15206
971
mi
from
Pittsburgh, PA
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Renton, Washington 98055
1402
mi
from
Renton, WA
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Sacramento, California 95821
1277
mi
from
Sacramento, CA
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San Diego, California 92120
1136
mi
from
San Diego, CA
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Sandy Springs, Georgia 30328
796
mi
from
Sandy Springs, GA
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Tucson, Arizona 85712
830
mi
from
Tucson, AZ
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Washington, D.C., District of Columbia 20036
?
mi
from
Washington, D.C.,
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West Jordan, Utah 84088
782
mi
from
West Jordan, UT
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