Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
NCT ID: NCT02013544
Last Updated: 2017-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
558 participants
INTERVENTIONAL
2014-02-28
2015-02-28
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 vaginal ovule daily for 12 weeks
Placebo
Prasterone
Prasterone (DHEA) vaginal ovule daily for 12 weeks
Prasterone (DHEA)
Interventions
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Placebo
Prasterone (DHEA)
Eligibility Criteria
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Inclusion 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
* 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
40 Years
80 Years
FEMALE
No
Sponsors
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EndoCeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fernand Labrie, M.D., Ph.D.
Role: STUDY_CHAIR
EndoCeutics Inc.
David F Archer, M.D.
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 # 83
San Diego, 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 # 45
Boynton Beach, Florida, United States
EndoCeutics site # 60
Lake Worth, Florida, United States
EndoCeutics site # 54
North Miami, Florida, United States
EndoCeutics site # 80
West Palm Beach, Florida, United States
EndoCeutics site # 23
Atlanta, Georgia, United States
EndoCeutics site # 55
Wichita, Kansas, United States
EndoCeutics site # 86
Louisville, Kentucky, United States
EndoCeutics site # 27
Lutherville, Maryland, United States
EndoCeutics site # 87
Lawrenceville, New Jersey, United States
EndoCeutics site # 81
Plainsboro, New Jersey, United States
EndoCeutics site # 05
Cleveland, Ohio, United States
EndoCeutics site # 15
Columbus, Ohio, United States
EndoCeutics site # 75
Philadelphia, Pennsylvania, United States
EndoCeutics site # 84
Corpus Christi, Texas, United States
EndoCeutics site # 82
Houston, Texas, United States
EndoCeutics site # 03
Norfolk, Virginia, United States
EndoCeutics site # 76
Seattle, Washington, United States
EndoCeutics site # 85
Burlington, Ontario, Canada
EndoCeutics site # 69
Corunna, Ontario, Canada
EndoCeutics site # 68
Sarnia, Ontario, Canada
EndoCeutics site # 73
Waterloo, Ontario, Canada
EndoCeutics site # 04
Drummondville, Quebec, Canada
EndoCeutics site # 12
Montreal, Quebec, Canada
EndoCeutics site # 79
Pointe-Claire, Quebec, Canada
EndoCeutics site # 02
Québec, Quebec, Canada
EndoCeutics site # 01
Québec, Quebec, Canada
EndoCeutics site # 77
Québec, Quebec, Canada
EndoCeutics site # 78
Québec, Quebec, Canada
EndoCeutics site # 18
Saint Romuald, Quebec, Canada
EndoCeutics site # 74
Sherbrooke, Quebec, Canada
EndoCeutics site # 67
Victoriaville, Quebec, Canada
Countries
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References
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Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.
Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.
Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
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.
Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.
Other Identifiers
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ERC-238
Identifier Type: -
Identifier Source: org_study_id
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