Back to resultsDehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Primary Purpose
Vaginal Atrophy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
DHEA
DHEA
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy focused on measuring Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
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
Sites / Locations
- EndoCeutics site # 39
- EndoCeutics site # 14
- EndoCeutics site # 65
- EndoCeutics site # 21
- EndoCeutics site # 30
- EndoCeutics site # 36
- EndoCeutics site # 52
- EndoCeutics site # 66
- EndoCeutics site # 42
- EndoCeutics site # 57
- EndoCeutics site # 61
- EndoCeutics site # 26
- EndoCeutics site # 60
- EndoCeutics site # 54
- EndoCeutics site # 56
- EndoCeutics site # 23
- EndoCeutics site # 10
- EndoCeutics site # 55
- EndoCeutics site # 27
- EndoCeutics site # 24
- EndoCeutics site # 50
- EndoCeutics site # 33
- EndoCeutics site # 05
- EndoCeutics site # 47
- EndoCeutics site # 15
- EndoCeutics site # 62
- EndoCeutics site # 64
- EndoCeutics site # 63
- EndoCeutics site # 53
- EndoCeutics site # 51
- EndoCeutics site # 09
- EndoCeutics site # 03
- EndoCeutics site # 13
- EndoCeutics site # 06
- EndoCeutics site # 59
- EndoCeutics site # 04
- EndoCeutics site # 12
- EndoCeutics site # 02
- EndoCeutics site # 01
- EndoCeutics site # 08
- EndoCeutics site # 11
- EndoCeutics site # 18
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
0.25% DHEA
0.5% DHEA
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Vaginal pH
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Secondary Outcome Measures
Change From Baseline to Week 12 in Severity of Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01358760
Brief Title
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoCeutics Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
Keywords
Vulvar/vaginal atrophy, Atrophic Vaginitis, Dehydroepiandrosterone, DHEA, Prasterone, Vaginorm, Menopause, Intrarosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
0.25% DHEA
Arm Type
Experimental
Arm Title
0.5% DHEA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo vaginal suppository
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
Prasterone, Dehydroepiandrosterone
Intervention Description
Vaginal suppository containing 0.25% (3.25 mg) DHEA
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
Prasterone, Dehydroepiandrosterone
Intervention Description
Vaginal suppository containing 0.5% (6.5 mg) DHEA
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Description
The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Description
The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Vaginal pH
Description
A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Description
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Severity of Dyspareunia
Description
The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Description
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Description
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Description
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Description
To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Archer, MD
Organizational Affiliation
Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
EndoCeutics site # 39
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
EndoCeutics site # 14
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
EndoCeutics site # 65
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
EndoCeutics site # 21
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
EndoCeutics site # 30
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
EndoCeutics site # 36
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
EndoCeutics site # 52
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
EndoCeutics site # 66
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
EndoCeutics site # 42
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
EndoCeutics site # 57
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
EndoCeutics site # 61
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
EndoCeutics site # 26
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
EndoCeutics site # 60
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
EndoCeutics site # 54
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
EndoCeutics site # 56
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
EndoCeutics site # 23
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
EndoCeutics site # 10
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
EndoCeutics site # 55
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
EndoCeutics site # 27
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285-6815
Country
United States
Facility Name
EndoCeutics site # 24
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
EndoCeutics site # 50
City
Neptune City
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
EndoCeutics site # 33
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
EndoCeutics site # 05
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
EndoCeutics site # 47
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
EndoCeutics site # 15
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
EndoCeutics site # 62
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02930
Country
United States
Facility Name
EndoCeutics site # 64
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
EndoCeutics site # 63
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
EndoCeutics site # 53
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
EndoCeutics site # 51
City
Sandy City
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
EndoCeutics site # 09
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
EndoCeutics site # 03
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
EndoCeutics site # 13
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4L7
Country
Canada
Facility Name
EndoCeutics site # 06
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
EndoCeutics site # 59
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
EndoCeutics site # 04
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
EndoCeutics site # 12
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
EndoCeutics site # 02
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
EndoCeutics site # 01
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 2L9
Country
Canada
Facility Name
EndoCeutics site # 08
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada
Facility Name
EndoCeutics site # 11
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
EndoCeutics site # 18
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25511551
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.
Results Reference
result
PubMed Identifier
25968836
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.
Results Reference
result
Learn more about this trial
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
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