Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Drug: Placebo; Drug: DHEA; Drug: DHEA

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4L7
      • EndoCeutics site # 13
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
      • EndoCeutics site # 06
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • EndoCeutics site # 59
  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
      • EndoCeutics site # 04
    • Montreal, Quebec, Canada, H4N 3C5
      • EndoCeutics site # 12
    • Quebec City, Quebec, Canada, G1S 2L6
      • EndoCeutics site # 02
    • Quebec City, Quebec, Canada, G1V 2L9
      • EndoCeutics site # 01
    • Shawinigan, Quebec, Canada, G9N 2H6
      • EndoCeutics site # 08
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • EndoCeutics site # 11
    • St-Romuald, Quebec, Canada, G6W 5M6
      • EndoCeutics site # 18
• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • EndoCeutics site # 39
  • Arizona
    • Tucson, Arizona, United States, 85712
      • EndoCeutics site # 14
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • EndoCeutics site # 65
  • California
    • Sacramento, California, United States, 95821
      • EndoCeutics site # 21
    • San Diego, California, United States, 92108
      • EndoCeutics site # 30
  • Colorado
    • Denver, Colorado, United States, 80218
      • EndoCeutics site # 36
    • Denver, Colorado, United States, 80220
      • EndoCeutics site # 52
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • EndoCeutics site # 66
    • Milford, Connecticut, United States, 06460
      • EndoCeutics site # 42
    • West Hartford, Connecticut, United States, 06117
      • EndoCeutics site # 57
  • Delaware
    • Newark, Delaware, United States, 19718
      • EndoCeutics site # 61
  • Florida
    • Jacksonville, Florida, United States, 32207
      • EndoCeutics site # 26
    • Lake Worth, Florida, United States, 33461
      • EndoCeutics site # 60
    • North Miami, Florida, United States, 33161
      • EndoCeutics site # 54
    • Pinellas Park, Florida, United States, 33781
      • EndoCeutics site # 56
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • EndoCeutics site # 23
  • Idaho
    • Meridian, Idaho, United States, 83642
      • EndoCeutics site # 10
  • Kansas
    • Wichita, Kansas, United States, 67226
      • EndoCeutics site # 55
  • Maryland
    • Baltimore, Maryland, United States, 21285-6815
      • EndoCeutics site # 27
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • EndoCeutics site # 24
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • EndoCeutics site # 50
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • EndoCeutics site # 33
    • Cleveland, Ohio, United States, 44122
      • EndoCeutics site # 05
    • Cleveland, Ohio, United States, 44124
      • EndoCeutics site # 47
    • Columbus, Ohio, United States, 43213
      • EndoCeutics site # 15
  • Rhode Island
    • Providence, Rhode Island, United States, 02930
      • EndoCeutics site # 62
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • EndoCeutics site # 64
    • Memphis, Tennessee, United States, 38120
      • EndoCeutics site # 63
  • Texas
    • San Antonio, Texas, United States, 78205
      • EndoCeutics site # 53
  • Utah
    • Sandy City, Utah, United States, 84070
      • EndoCeutics site # 51
    • West Jordan, Utah, United States, 84088
      • EndoCeutics site # 09
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • EndoCeutics site # 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo vaginal suppository
Experimental: 0.25% DHEA	Drug: DHEA; Vaginal suppository containing 0.25% (3.25 mg) DHEA; Other Names: Prasterone, Dehydroepiandrosterone; Drug: DHEA; Vaginal suppository containing 0.5% (6.5 mg) DHEA; Other Names: Prasterone, Dehydroepiandrosterone
Experimental: 0.5% DHEA	Drug: DHEA; Vaginal suppository containing 0.25% (3.25 mg) DHEA; Other Names: Prasterone, Dehydroepiandrosterone; Drug: DHEA; Vaginal suppository containing 0.5% (6.5 mg) DHEA; Other Names: Prasterone, Dehydroepiandrosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12
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.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: EndoCeutics Inc.
• Investigators: Principal Investigator: David Archer, MD, Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa; Vulvar/vaginal atrophy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: ERC-234