Clinical trial NCT01256684: DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
Official title: DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)
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: 255
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 confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.


Eligibility criteria: Main Inclusion Criteria:

* Postmenopausal women (hysterectomized or 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.
* For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study.

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: 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 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 # 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: Boynton Beach
country: United States
facility: EndoCeutics site # 45
state: Florida
city: Jacksonville
country: United States
facility: EndoCeutics site # 26
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: Moorestown
country: United States
facility: EndoCeutics site # 28
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: Cleveland
country: United States
facility: EndoCeutics site # 05
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: 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 # 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: Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.
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.