Back to resultsDHEA Against Vaginal Atrophy - Safety Study of 12 Months
Primary Purpose
Vaginal Atrophy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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
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.
Sites / Locations
- EndoCeutics site # 39
- EndoCeutics site # 14
- EndoCeutics site # 21
- EndoCeutics site # 30
- EndoCeutics site # 17
- EndoCeutics site # 36
- EndoCeutics site # 42
- EndoCeutics site # 07
- EndoCeutics site # 45
- EndoCeutics site # 26
- EndoCeutics site # 41
- EndoCeutics site # 23
- EndoCeutics site # 10
- EndoCeutics site # 27
- EndoCeutics site # 22
- EndoCeutics site # 25
- EndoCeutics site # 24
- EndoCeutics site # 28
- EndoCeutics site # 50
- EndoCeutics site # 44
- EndoCeutics site # 19
- EndoCeutics site # 16
- EndoCeutics site # 33
- EndoCeutics site # 05
- EndoCeutics site # 47
- EndoCeutics site # 15
- EndoCeutics site # 35
- EndoCeutics site # 09
- EndoCeutics site # 31
- EndoCeutics site # 03
- EndoCeutics site # 38
- EndoCeutics site # 13
- EndoCeutics site # 06
- EndoCeutics site # 04
- EndoCeutics site # 34
- 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 Type
Experimental
Arm Label
DHEA
Arm Description
0.5% DHEA (intravaginal)
Outcomes
Primary Outcome Measures
Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Secondary Outcome Measures
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).
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 52 as well as the change from Baseline to Week 52 are presented.
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).
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 52 as well as the change from Baseline to Week 52 are presented.
Change From Baseline to Week 52 of 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 52 as well as the change from Baseline to Week 52 are presented.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia
The severity of dyspareunia was evaluated by a questionnaire. 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 52 as well as the change from Baseline to Week 52 are presented.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal 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 52 as well as the change from Baseline to Week 52 are presented.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching 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 52 as well as the change from Baseline to Week 52 are presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256671
Brief Title
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Official Title
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 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 assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHEA
Arm Type
Experimental
Arm Description
0.5% DHEA (intravaginal)
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
Prasterone, Dehydroepiandrosterone, Vaginorm
Intervention Description
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Primary Outcome Measure Information:
Title
Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
Description
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Time Frame
Baseline and Week 52 (or discontinuation)
Title
Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
Description
The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).
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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Title
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).
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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Title
Change From Baseline to Week 52 of 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Title
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia
Description
The severity of dyspareunia was evaluated by a questionnaire. 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Title
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
Description
The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
Title
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
Description
The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame
Baseline and Week 52
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F 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 # 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 # 17
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
EndoCeutics site # 36
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
EndoCeutics site # 42
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
EndoCeutics site # 07
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
EndoCeutics site # 45
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
EndoCeutics site # 26
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
EndoCeutics site # 41
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
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 # 27
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285-6815
Country
United States
Facility Name
EndoCeutics site # 22
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
EndoCeutics site # 25
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
EndoCeutics site # 24
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
EndoCeutics site # 28
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
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 # 44
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
EndoCeutics site # 19
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
EndoCeutics site # 16
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
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 # 35
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
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 # 31
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
EndoCeutics site # 03
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
EndoCeutics site # 38
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
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 # 04
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
EndoCeutics site # 34
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
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
25771041
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.
Results Reference
result
PubMed Identifier
26725467
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.
Results Reference
result
PubMed Identifier
26509785
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.
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
PubMed Identifier
26972555
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.
Results Reference
result
Learn more about this trial
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
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