Clinical trial NCT01358760: Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
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: 2011-05-24
Enrollment: 450
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 Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with 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 who have self-identified symptom(s) of vaginal atrophy
* For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

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: 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 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 Vaginal pH
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Severity of Dyspareunia
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: Little Rock
country: United States
facility: EndoCeutics site # 65
state: Arkansas
city: Sacramento
country: United States
facility: EndoCeutics site # 21
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: Danbury
country: United States
facility: EndoCeutics site # 66
state: Connecticut
city: Milford
country: United States
facility: EndoCeutics site # 42
state: Connecticut
city: West Hartford
country: United States
facility: EndoCeutics site # 57
state: Connecticut
city: Newark
country: United States
facility: EndoCeutics site # 61
state: Delaware
city: Jacksonville
country: United States
facility: EndoCeutics site # 26
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: Pinellas Park
country: United States
facility: EndoCeutics site # 56
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: Wichita
country: United States
facility: EndoCeutics site # 55
state: Kansas
city: Baltimore
country: United States
facility: EndoCeutics site # 27
state: Maryland
city: Omaha
country: United States
facility: EndoCeutics site # 24
state: Nebraska
city: Neptune City
country: United States
facility: EndoCeutics site # 50
state: New Jersey
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: Providence
country: United States
facility: EndoCeutics site # 62
state: Rhode Island
city: Jackson
country: United States
facility: EndoCeutics site # 64
state: Tennessee
city: Memphis
country: United States
facility: EndoCeutics site # 63
state: Tennessee
city: San Antonio
country: United States
facility: EndoCeutics site # 53
state: Texas
city: Sandy City
country: United States
facility: EndoCeutics site # 51
state: Utah
city: West Jordan
country: United States
facility: EndoCeutics site # 09
state: Utah
city: Norfolk
country: United States
facility: EndoCeutics site # 03
state: Virginia
city: Calgary
country: Canada
facility: EndoCeutics site # 13
state: Alberta
city: Bathurst
country: Canada
facility: EndoCeutics site # 06
state: New Brunswick
city: Toronto
country: Canada
facility: EndoCeutics site # 59
state: Ontario
city: Drummondville
country: Canada
facility: EndoCeutics site # 04
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 Archer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3.
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.