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

Use our guide to learn which trials are right for you!

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
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Atlanta, Georgia 30328
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boynton Beach, Florida 33472
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Burlington, Ontario
?
mi
from
Burlington,
Click here to add this to my saved trials
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Denver, Colorado 80209
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80209
?
mi
from
Denver, CO
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lake Worth, Florida 33461
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Louisville, Kentucky 40291
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lutherville, Maryland 21093
?
mi
from
Lutherville, MD
Click here to add this to my saved trials
Montgomery, Alabama 36117
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
North Miami, Florida 33161
?
mi
from
North Miami, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plainsboro, New Jersey 08536
?
mi
from
Plainsboro, NJ
Click here to add this to my saved trials
Sacramento, California 95821
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Seattle, Washington 98105
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tucson, Arizona 85712
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Palm Beach, Florida 33409
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Whichita, Kansas 67226
?
mi
from
Whichita, KS
Click here to add this to my saved trials