Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2010-12-31
2011-11-30
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; daily dosing with one suppository for 12 weeks.
0.5% DHEA
DHEA
Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Interventions
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Placebo
Placebo vaginal suppository
DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA
Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
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 screening 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 F 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 # 21
Sacramento, California, United States
EndoCeutics site # 30
San Diego, California, United States
EndoCeutics site # 17
San Diego, California, United States
EndoCeutics site # 36
Denver, Colorado, United States
EndoCeutics site # 42
Milford, Connecticut, United States
EndoCeutics site # 45
Boynton Beach, Florida, United States
EndoCeutics site # 26
Jacksonville, Florida, United States
EndoCeutics site # 23
Sandy Springs, Georgia, United States
EndoCeutics site # 10
Meridian, Idaho, United States
EndoCeutics site # 27
Baltimore, Maryland, United States
EndoCeutics site # 22
Kalamazoo, Michigan, United States
EndoCeutics site # 25
Lincoln, Nebraska, United States
EndoCeutics site # 28
Moorestown, New Jersey, United States
EndoCeutics site # 44
New Brunswick, New Jersey, United States
EndoCeutics site # 19
New York, New York, United States
EndoCeutics site # 16
Durham, North Carolina, United States
EndoCeutics site # 05
Cleveland, Ohio, United States
EndoCeutics site # 15
Columbus, Ohio, United States
EndoCeutics site # 35
Pittsburgh, Pennsylvania, United States
EndoCeutics site # 09
West Jordan, Utah, United States
EndoCeutics site # 31
Charlottesville, Virginia, United States
EndoCeutics site # 03
Norfolk, Virginia, United States
EndoCeutics site # 13
Calgary, Alberta, Canada
EndoCeutics site # 06
Bathurst, New Brunswick, 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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Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
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.
Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.
Other Identifiers
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ERC-231
Identifier Type: -
Identifier Source: org_study_id
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