Clinical trial NCT01256671: DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Official title: DHEA Against Vaginal Atrophy - Safety Study of 12 Months
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: 2010-12-08
Enrollment: 530
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.


Eligibility criteria: Main Inclusion Criteria:

* Postmenopausal women (non-hysterectomized)
* 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).

Main Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* 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.

Primary outcomes:
measure: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
timeFrame: Baseline and Week 52 (or discontinuation)
measure: Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).
timeFrame: Baseline and Week 52
measure: Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).
timeFrame: Baseline and Week 52
measure: Change From Baseline to Week 52 of Vaginal pH.
timeFrame: Baseline and Week 52
measure: Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia
timeFrame: Baseline and Week 52
measure: Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
timeFrame: Baseline and Week 52
measure: Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
timeFrame: Baseline and Week 52
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 # 30
state: California
city: San Diego
country: United States
facility: EndoCeutics site # 17
state: California
city: Denver
country: United States
facility: EndoCeutics site # 36
state: Colorado
city: Milford
country: United States
facility: EndoCeutics site # 42
state: Connecticut
city: Washington, D.C.
country: United States
facility: EndoCeutics site # 07
state: District of Columbia
city: Boynton Beach
country: United States
facility: EndoCeutics site # 45
state: Florida
city: Jacksonville
country: United States
facility: EndoCeutics site # 26
state: Florida
city: West Palm Beach
country: United States
facility: EndoCeutics site # 41
state: Florida
city: Sandy Springs
country: United States
facility: EndoCeutics site # 23
state: Georgia
city: Meridian
country: United States
facility: EndoCeutics site # 10
state: Idaho
city: Baltimore
country: United States
facility: EndoCeutics site # 27
state: Maryland
city: Kalamazoo
country: United States
facility: EndoCeutics site # 22
state: Michigan
city: Lincoln
country: United States
facility: EndoCeutics site # 25
state: Nebraska
city: Omaha
country: United States
facility: EndoCeutics site # 24
state: Nebraska
city: Moorestown
country: United States
facility: EndoCeutics site # 28
state: New Jersey
city: Neptune City
country: United States
facility: EndoCeutics site # 50
state: New Jersey
city: New Brunswick
country: United States
facility: EndoCeutics site # 44
state: New Jersey
city: New York
country: United States
facility: EndoCeutics site # 19
state: New York
city: Durham
country: United States
facility: EndoCeutics site # 16
state: North Carolina
city: Beachwood
country: United States
facility: EndoCeutics site # 33
state: Ohio
city: Cleveland
country: United States
facility: EndoCeutics site # 05
state: Ohio
city: Cleveland
country: United States
facility: EndoCeutics site # 47
state: Ohio
city: Columbus
country: United States
facility: EndoCeutics site # 15
state: Ohio
city: Pittsburgh
country: United States
facility: EndoCeutics site # 35
state: Pennsylvania
city: West Jordan
country: United States
facility: EndoCeutics site # 09
state: Utah
city: Charlottesville
country: United States
facility: EndoCeutics site # 31
state: Virginia
city: Norfolk
country: United States
facility: EndoCeutics site # 03
state: Virginia
city: Renton
country: United States
facility: EndoCeutics site # 38
state: Washington
city: Calgary
country: Canada
facility: EndoCeutics site # 13
state: Alberta
city: Bathurst
country: Canada
facility: EndoCeutics site # 06
state: New Brunswick
city: Drummondville
country: Canada
facility: EndoCeutics site # 04
state: Quebec
city: Montreal
country: Canada
facility: EndoCeutics site # 34
state: Quebec
city: Montreal
country: Canada
facility: EndoCeutics site # 12
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: Shawinigan
country: Canada
facility: EndoCeutics site # 08
state: Quebec
city: Sherbrooke
country: Canada
facility: EndoCeutics site # 11
state: Quebec
city: St-Romuald
country: Canada
facility: EndoCeutics site # 18
state: Quebec
Study officials:
affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
name: David F Archer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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: 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.