Clinical trial NCT01846442: Topical DHEA Against Vaginal Atrophy
Official title: Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Atrophy
Keywords: Vulvar/vaginal atrophy
Atrophic Vaginitis
Dehydroepiandrosterone
DHEA
Prasterone
Vaginorm
Menopause
Intrarosa
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 218
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (non hysterectomized or hysterectomized)
* Women between 40 and 75 years of age
* Willing to participate in the study and sign an informed consent
* Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
* Women having a vaginal pH above 5
* Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
* The administration of any investigational drug within 30 days of screening visit
* Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
* Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry

Primary outcomes:
measure: Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
timeFrame: Baseline and Week 12
measure: Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
timeFrame: Baseline and Week 12
measure: Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
timeFrame: Baseline and Week 12
measure: Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 of Vaginal Secretions
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 of Vaginal Epithelial Integrity
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 of Vaginal Color
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: EndoCeutics site # 05
state: Ohio
city: Norfolk
country: United States
facility: EndoCeutics site # 03
state: Virginia
city: Montreal
country: Canada
facility: EndoCeutics site # 10
state: Quebec
city: Montreal
country: Canada
facility: EndoCeutics site # 09
state: Quebec
city: Shawinigan
country: Canada
facility: EndoCeutics site # 08
state: Quebec
city: Sherbrooke
country: Canada
facility: EndoCeutics site # 11
state: Quebec
city: Quebec
country: Canada
facility: EndoCeutics site # 02
city: Quebec
country: Canada
facility: EndoCeutics site # 01
Study officials:
affiliation: Clinical Research Center, Eastern Virginia Medical Scholl, Norfolk, VA
name: David F Archer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berube R, Belanger P, Berger L, Gilbert L, Martel C, Balser J. Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration. Menopause. 2009 Sep-Oct;16(5):897-906. doi: 10.1097/gme.0b013e31819e8930.
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Menopause. 2009 Sep-Oct;16(5):907-22. doi: 10.1097/gme.0b013e31819e8e2d.
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Martel C, Balser J. High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy. Gynecol Endocrinol. 2010 Jul;26(7):524-32. doi: 10.3109/09513590903511547.
citation: Labrie F, Archer DF, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric. 2011 Apr;14(2):282-8. doi: 10.3109/13697137.2010.535226. Epub 2011 Jan 18.
citation: Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Gilbert L, Martel C, Balser J. Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women. J Sex Med. 2014 Jul;11(7):1766-85. doi: 10.1111/jsm.12517. Epub 2014 Apr 28.
citation: 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.
citation: Labrie F. Intravaginal DHEA, by a strictly local action, exerts beneficial effects on both vaginal atrophy symptoms and sexual dysfunction. Horm Mol Biol Clin Investig. 2010 Dec 1;4(1):499-507. doi: 10.1515/HMBCI.2010.064.
citation: 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.