Clinical trial NCT02013544: Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Atrophy
Keywords: Vulvovaginal atrophy (VVA)
Vaginal atrophy
Atrophic vaginitis
prasterone
DHEA
Intrarosa
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 558
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
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 confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.


Eligibility criteria: Inclusion Criteria:

Main 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:

Main 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

Primary outcomes:
measure: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Vaginal pH
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Severity of Vaginal Dryness
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: EndoCeutics site # 39
state: Alabama
city: Tucson
country: United States
facility: EndoCeutics site # 14
state: Arizona
city: Sacramento
country: United States
facility: EndoCeutics site # 21
state: California
city: San Diego
country: United States
facility: EndoCeutics site # 83
state: California
city: San Diego
country: United States
facility: EndoCeutics site # 30
state: California
city: Denver
country: United States
facility: EndoCeutics site # 36
state: Colorado
city: Denver
country: United States
facility: EndoCeutics site # 52
state: Colorado
city: Boynton Beach
country: United States
facility: EndoCeutics site # 45
state: Florida
city: Lake Worth
country: United States
facility: EndoCeutics site # 60
state: Florida
city: North Miami
country: United States
facility: EndoCeutics site # 54
state: Florida
city: West Palm Beach
country: United States
facility: EndoCeutics site # 80
state: Florida
city: Atlanta
country: United States
facility: EndoCeutics site # 23
state: Georgia
city: Wichita
country: United States
facility: EndoCeutics site # 55
state: Kansas
city: Louisville
country: United States
facility: EndoCeutics site # 86
state: Kentucky
city: Lutherville
country: United States
facility: EndoCeutics site # 27
state: Maryland
city: Lawrenceville
country: United States
facility: EndoCeutics site # 87
state: New Jersey
city: Plainsboro
country: United States
facility: EndoCeutics site # 81
state: New Jersey
city: Cleveland
country: United States
facility: EndoCeutics site # 05
state: Ohio
city: Columbus
country: United States
facility: EndoCeutics site # 15
state: Ohio
city: Philadelphia
country: United States
facility: EndoCeutics site # 75
state: Pennsylvania
city: Corpus Christi
country: United States
facility: EndoCeutics site # 84
state: Texas
city: Houston
country: United States
facility: EndoCeutics site # 82
state: Texas
city: Norfolk
country: United States
facility: EndoCeutics site # 03
state: Virginia
city: Seattle
country: United States
facility: EndoCeutics site # 76
state: Washington
city: Burlington
country: Canada
facility: EndoCeutics site # 85
state: Ontario
city: Corunna
country: Canada
facility: EndoCeutics site # 69
state: Ontario
city: Sarnia
country: Canada
facility: EndoCeutics site # 68
state: Ontario
city: Waterloo
country: Canada
facility: EndoCeutics site # 73
state: Ontario
city: Drummondville
country: Canada
facility: EndoCeutics site # 04
state: Quebec
city: Montreal
country: Canada
facility: EndoCeutics site # 12
state: Quebec
city: Pointe-Claire
country: Canada
facility: EndoCeutics site # 79
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 02
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 01
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 77
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 78
state: Quebec
city: Sherbrooke
country: Canada
facility: EndoCeutics site # 74
state: Quebec
city: St-Romuald
country: Canada
facility: EndoCeutics site # 18
state: Quebec
city: Victoriaville
country: Canada
facility: EndoCeutics site # 67
state: Quebec
Study officials:
affiliation: EndoCeutics Inc.
name: Fernand Labrie, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
name: David F Archer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.