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Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Primary Purpose

Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Prasterone (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 Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, prasterone, DHEA, Intrarosa

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Main criteria:

  • Postmenopausal women (hysterectomized or not)
  • Women between 40 and 80 years of age
  • Women having ≤5% of superficial cells on vaginal smear at baseline
  • Women having a vaginal pH above 5 at baseline
  • Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
  • Willing to participate in the study and sign an informed consent

Exclusion Criteria:

Main criteria:

  • Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
  • Previous diagnosis of cancer, except skin cancer (non melanoma)
  • Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
  • The administration of any investigational drug within 30 days of screening visit
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology

Sites / Locations

  • EndoCeutics site # 39
  • EndoCeutics site # 14
  • EndoCeutics site # 21
  • EndoCeutics site # 83
  • EndoCeutics site # 30
  • EndoCeutics site # 36
  • EndoCeutics site # 52
  • EndoCeutics site # 45
  • EndoCeutics site # 60
  • EndoCeutics site # 54
  • EndoCeutics site # 80
  • EndoCeutics site # 23
  • EndoCeutics site # 55
  • EndoCeutics site # 86
  • EndoCeutics site # 27
  • EndoCeutics site # 87
  • EndoCeutics site # 81
  • EndoCeutics site # 05
  • EndoCeutics site # 15
  • EndoCeutics site # 75
  • EndoCeutics site # 84
  • EndoCeutics site # 82
  • EndoCeutics site # 03
  • EndoCeutics site # 76
  • EndoCeutics site # 85
  • EndoCeutics site # 69
  • EndoCeutics site # 68
  • EndoCeutics site # 73
  • EndoCeutics site # 04
  • EndoCeutics site # 12
  • EndoCeutics site # 79
  • EndoCeutics site # 02
  • EndoCeutics site # 01
  • EndoCeutics site # 77
  • EndoCeutics site # 78
  • EndoCeutics site # 74
  • EndoCeutics site # 18
  • EndoCeutics site # 67

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Prasterone

Arm Description

Placebo vaginal ovule daily for 12 weeks

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Outcomes

Primary Outcome Measures

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 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 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 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

First Posted
December 9, 2013
Last Updated
May 30, 2017
Sponsor
EndoCeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02013544
Brief Title
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoCeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
Keywords
Vulvovaginal atrophy (VVA), Vaginal atrophy, Atrophic vaginitis, prasterone, DHEA, Intrarosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal ovule daily for 12 weeks
Arm Title
Prasterone
Arm Type
Experimental
Arm Description
Prasterone (DHEA) vaginal ovule daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Prasterone (DHEA)
Primary Outcome Measure Information:
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 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 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 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
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Main criteria: Postmenopausal women (hysterectomized or not) Women between 40 and 80 years of age Women having ≤5% of superficial cells on vaginal smear at baseline Women having a vaginal pH above 5 at baseline Women who have self-identified moderate or severe symptom(s) of vaginal atrophy Willing to participate in the study and sign an informed consent Exclusion Criteria: Main criteria: Previous enrollment in EndoCeutics studies performed with intravaginal DHEA Previous diagnosis of cancer, except skin cancer (non melanoma) Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication The administration of any investigational drug within 30 days of screening visit Clinically significant abnormal serum biochemistry, urinalysis or hematology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernand Labrie, M.D., Ph.D.
Organizational Affiliation
EndoCeutics Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David F Archer, M.D.
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 # 83
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
80209
Country
United States
Facility Name
EndoCeutics site # 52
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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 # 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 # 80
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
EndoCeutics site # 23
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
EndoCeutics site # 55
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
EndoCeutics site # 86
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
EndoCeutics site # 27
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
EndoCeutics site # 87
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
EndoCeutics site # 81
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
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 # 75
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114-1029
Country
United States
Facility Name
EndoCeutics site # 84
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
EndoCeutics site # 82
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
EndoCeutics site # 03
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
EndoCeutics site # 76
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
EndoCeutics site # 85
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4B8
Country
Canada
Facility Name
EndoCeutics site # 69
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N1G0
Country
Canada
Facility Name
EndoCeutics site # 68
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
EndoCeutics site # 73
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
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 # 79
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
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 # 77
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
EndoCeutics site # 78
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
EndoCeutics site # 74
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
EndoCeutics site # 18
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
EndoCeutics site # 67
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26291918
Citation
Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.
Results Reference
result
PubMed Identifier
26597311
Citation
Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
Results Reference
result
PubMed Identifier
26517756
Citation
Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.
Results Reference
result
PubMed Identifier
26731686
Citation
Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.
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
PubMed Identifier
26634942
Citation
Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.
Results Reference
result

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Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

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