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
Denver, Colorado 80209
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Atlanta, Georgia 30328
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Atlanta, GA
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Boynton Beach, Florida 33472
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Burlington, Ontario
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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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Corpus Christi, Texas 78414
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Corpus Christi, TX
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Denver, Colorado 80209
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Denver, CO
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Houston, Texas 77030
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Houston, TX
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Lake Worth, Florida 33461
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Lake Worth, FL
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Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Louisville, Kentucky 40291
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Louisville, KY
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Lutherville, Maryland 21093
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Lutherville, MD
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Montgomery, Alabama 36117
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Montgomery, AL
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Norfolk, Virginia 23507
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Norfolk, VA
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North Miami, Florida 33161
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North Miami, FL
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Philadelphia, Pennsylvania 19114
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Philadelphia, PA
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Plainsboro, New Jersey 08536
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Plainsboro, NJ
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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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San Diego, California 92120
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San Diego, CA
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Seattle, Washington 98105
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Seattle, WA
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Tucson, Arizona 85712
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Tucson, AZ
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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Whichita, Kansas 67226
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Whichita, KS
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