Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:40 - 80
Updated:4/21/2016
Start Date:February 2014
End Date:February 2015

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The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on
symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects
exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.


Inclusion Criteria:

Main criteria:

- Postmenopausal women (hysterectomized or not)

- Women between 40 and 80 years of age

- Women having ≤5% of superficial cells on vaginal smear at baseline

- Women having a vaginal pH above 5 at baseline

- Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

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

Exclusion Criteria:

Main criteria:

- Previous enrollment in EndoCeutics studies performed with intravaginal DHEA

- Previous diagnosis of cancer, except skin cancer (non melanoma)

- Clinically significant metabolic or endocrine disease (including diabetes mellitus)
not controlled by medication

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

- Clinically significant abnormal serum biochemistry, urinalysis or hematology
We found this trial at
25
sites
Corpus Christi, Texas 78414
1174
mi
from 43215
Corpus Christi, TX
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Atlanta, Georgia 30328
424
mi
from 43215
Atlanta, GA
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Boynton Beach, Florida 33472
943
mi
from 43215
Boynton Beach, FL
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Burlington, Ontario
285
mi
from 43215
Burlington,
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Cleveland, Ohio 44122
130
mi
from 43215
Cleveland, OH
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Columbus, Ohio 43213
7
mi
from 43215
Columbus, OH
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Denver, Colorado 80209
1160
mi
from 43215
Denver, CO
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Denver, Colorado 80209
1160
mi
from 43215
Denver, CO
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Houston, Texas 77030
991
mi
from 43215
Houston, TX
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Lake Worth, Florida 33461
937
mi
from 43215
Lake Worth, FL
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Lawrenceville, New Jersey 08648
438
mi
from 43215
Lawrenceville, NJ
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Louisville, Kentucky 40291
187
mi
from 43215
Louisville, KY
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Lutherville, Maryland 21093
342
mi
from 43215
Lutherville, MD
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Montgomery, Alabama 36117
552
mi
from 43215
Montgomery, AL
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Norfolk, Virginia 23507
423
mi
from 43215
Norfolk, VA
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North Miami, Florida 33161
986
mi
from 43215
North Miami, FL
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Philadelphia, Pennsylvania 19114
416
mi
from 43215
Philadelphia, PA
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Plainsboro, New Jersey 08536
446
mi
from 43215
Plainsboro, NJ
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Sacramento, California 95821
2037
mi
from 43215
Sacramento, CA
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San Diego, California 92120
1944
mi
from 43215
San Diego, CA
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San Diego, California 92120
1944
mi
from 43215
San Diego, CA
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Seattle, Washington 98105
2004
mi
from 43215
Seattle, WA
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Tucson, Arizona 85712
1636
mi
from 43215
Tucson, AZ
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West Palm Beach, Florida 33409
931
mi
from 43215
West Palm Beach, FL
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Whichita, Kansas 67226
777
mi
from 43215
Whichita, KS
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