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
San Diego, California 92120
103
mi
from 91732
San Diego, CA
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Atlanta, Georgia 30328
1917
mi
from 91732
Atlanta, GA
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Boynton Beach, Florida 33472
2309
mi
from 91732
Boynton Beach, FL
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Burlington, Ontario
2136
mi
from 91732
Burlington,
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Cleveland, Ohio 44122
2041
mi
from 91732
Cleveland, OH
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Columbus, Ohio 43213
1967
mi
from 91732
Columbus, OH
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Corpus Christi, Texas 78414
1293
mi
from 91732
Corpus Christi, TX
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Denver, Colorado 80209
818
mi
from 91732
Denver, CO
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Denver, Colorado 80209
818
mi
from 91732
Denver, CO
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Houston, Texas 77030
1358
mi
from 91732
Houston, TX
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Lake Worth, Florida 33461
2307
mi
from 91732
Lake Worth, FL
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Lawrenceville, New Jersey 08648
2396
mi
from 91732
Lawrenceville, NJ
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Louisville, Kentucky 40291
1823
mi
from 91732
Louisville, KY
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Lutherville, Maryland 21093
2300
mi
from 91732
Lutherville, MD
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Montgomery, Alabama 36117
1835
mi
from 91732
Montgomery, AL
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Norfolk, Virginia 23507
2337
mi
from 91732
Norfolk, VA
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North Miami, Florida 33161
2319
mi
from 91732
North Miami, FL
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Philadelphia, Pennsylvania 19114
2375
mi
from 91732
Philadelphia, PA
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Plainsboro, New Jersey 08536
2404
mi
from 91732
Plainsboro, NJ
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Sacramento, California 95821
365
mi
from 91732
Sacramento, CA
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San Diego, California 92120
103
mi
from 91732
San Diego, CA
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Seattle, Washington 98105
964
mi
from 91732
Seattle, WA
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Tucson, Arizona 85712
430
mi
from 91732
Tucson, AZ
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West Palm Beach, Florida 33409
2304
mi
from 91732
West Palm Beach, FL
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Whichita, Kansas 67226
1188
mi
from 91732
Whichita, KS
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