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DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Primary Purpose

Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
DHEA
DHEA
Sponsored by
EndoCeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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 # 45
  • EndoCeutics site # 26
  • EndoCeutics site # 23
  • EndoCeutics site # 10
  • EndoCeutics site # 27
  • EndoCeutics site # 22
  • EndoCeutics site # 25
  • EndoCeutics site # 28
  • EndoCeutics site # 44
  • EndoCeutics site # 19
  • EndoCeutics site # 16
  • EndoCeutics site # 05
  • EndoCeutics site # 15
  • EndoCeutics site # 35
  • EndoCeutics site # 09
  • EndoCeutics site # 31
  • EndoCeutics site # 03
  • EndoCeutics site # 13
  • EndoCeutics site # 06
  • 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 cell 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 the 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 cell 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 the 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 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.

Secondary Outcome Measures

Change From Baseline to Week 12 in Severity of Vaginal Dryness
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. 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 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then analyzed using the 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

First Posted
December 3, 2010
Last Updated
May 31, 2017
Sponsor
EndoCeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01256684
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (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 confirm 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
255 (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; daily dosing with one suppository for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
Prasterone, Dehydroepiandrosterone
Intervention Description
Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
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 cell 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 the 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 cell 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 the 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 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
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Severity of Vaginal Dryness
Description
The severity of vaginal dryness was evaluated by a questionnaire filled out by women. 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 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then 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 DHEA suppositories, 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 then analyzed using the 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
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.
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 # 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 # 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 # 28
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
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 # 05
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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 # 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 # 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
25734980
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.
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

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DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

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