DHEA Against Vaginal Atrophy - Safety Study of 12 Months
NCT ID: NCT01256671
Last Updated: 2017-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2010-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DHEA
0.5% DHEA (intravaginal)
DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Interventions
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DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 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.
* Willing to have endometrial biopsy at screening and end of study (Week 52).
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 # 07
Washington D.C., District of Columbia, United States
EndoCeutics site # 45
Boynton Beach, Florida, United States
EndoCeutics site # 26
Jacksonville, Florida, United States
EndoCeutics site # 41
West Palm Beach, 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 # 24
Omaha, Nebraska, United States
EndoCeutics site # 28
Moorestown, New Jersey, United States
EndoCeutics site # 50
Neptune City, 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 # 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 # 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 # 38
Renton, Washington, United States
EndoCeutics site # 13
Calgary, Alberta, Canada
EndoCeutics site # 06
Bathurst, New Brunswick, Canada
EndoCeutics site # 04
Drummondville, Quebec, Canada
EndoCeutics site # 34
Montreal, 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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Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Cote I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur E; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.
Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.
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-230
Identifier Type: -
Identifier Source: org_study_id