Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2011-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo vaginal suppository
0.25% DHEA
DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA
0.5% DHEA
DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA
Interventions
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Placebo
Placebo vaginal suppository
DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA
DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study
Exclusion Criteria
* 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
40 Years
75 Years
FEMALE
No
Sponsors
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EndoCeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Archer, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
Locations
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EndoCeutics site # 39
Montgomery, Alabama, United States
EndoCeutics site # 14
Tucson, Arizona, United States
EndoCeutics site # 65
Little Rock, Arkansas, United States
EndoCeutics site # 21
Sacramento, California, United States
EndoCeutics site # 30
San Diego, California, United States
EndoCeutics site # 36
Denver, Colorado, United States
EndoCeutics site # 52
Denver, Colorado, United States
EndoCeutics site # 66
Danbury, Connecticut, United States
EndoCeutics site # 42
Milford, Connecticut, United States
EndoCeutics site # 57
West Hartford, Connecticut, United States
EndoCeutics site # 61
Newark, Delaware, United States
EndoCeutics site # 26
Jacksonville, Florida, United States
EndoCeutics site # 60
Lake Worth, Florida, United States
EndoCeutics site # 54
North Miami, Florida, United States
EndoCeutics site # 56
Pinellas Park, Florida, United States
EndoCeutics site # 23
Sandy Springs, Georgia, United States
EndoCeutics site # 10
Meridian, Idaho, United States
EndoCeutics site # 55
Wichita, Kansas, United States
EndoCeutics site # 27
Baltimore, Maryland, United States
EndoCeutics site # 24
Omaha, Nebraska, United States
EndoCeutics site # 50
Neptune City, New Jersey, United States
EndoCeutics site # 33
Beachwood, Ohio, United States
EndoCeutics site # 05
Cleveland, Ohio, United States
EndoCeutics site # 47
Cleveland, Ohio, United States
EndoCeutics site # 15
Columbus, Ohio, United States
EndoCeutics site # 62
Providence, Rhode Island, United States
EndoCeutics site # 64
Jackson, Tennessee, United States
EndoCeutics site # 63
Memphis, Tennessee, United States
EndoCeutics site # 53
San Antonio, Texas, United States
EndoCeutics site # 51
Sandy City, Utah, United States
EndoCeutics site # 09
West Jordan, Utah, United States
EndoCeutics site # 03
Norfolk, Virginia, United States
EndoCeutics site # 13
Calgary, Alberta, Canada
EndoCeutics site # 06
Bathurst, New Brunswick, Canada
EndoCeutics site # 59
Toronto, Ontario, Canada
EndoCeutics site # 04
Drummondville, Quebec, Canada
EndoCeutics site # 12
Montreal, Quebec, Canada
EndoCeutics site # 02
Québec, Quebec, Canada
EndoCeutics site # 01
Québec, Quebec, Canada
EndoCeutics site # 18
Saint Romuald, Quebec, Canada
EndoCeutics site # 08
Shawinigan, Quebec, Canada
EndoCeutics site # 11
Sherbrooke, Quebec, Canada
Countries
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References
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Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3.
Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.
Other Identifiers
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ERC-234
Identifier Type: -
Identifier Source: org_study_id
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