Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

NCT01358760 | Completed Phase 3 Results DMC

• 1 other identifier: ERC-234
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 42

Brief Summary

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

Conditions

Vaginal Atrophy

Keywords

Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change From Baseline to Week 12 in Severity of Dyspareunia

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color

  Baseline and Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

0.25% DHEA

EXPERIMENTAL

Drug: DHEA

0.5% DHEA

EXPERIMENTAL

Drug: DHEA

Interventions

Placebo DRUG

Placebo vaginal suppository

Placebo

DHEA DRUG

Vaginal suppository containing 0.25% (3.25 mg) DHEA

Also known as: Prasterone, Dehydroepiandrosterone

0.25% DHEA

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EndoCeutics Inc.: lead

Study Sites (42)

EndoCeutics site # 39

Montgomery, Alabama, 36117, United States

Location

EndoCeutics site # 14

Tucson, Arizona, 85712, United States

Location

EndoCeutics site # 65

Little Rock, Arkansas, 72204, United States

Location

EndoCeutics site # 21

Sacramento, California, 95821, United States

Location

EndoCeutics site # 30

San Diego, California, 92108, United States

Location

EndoCeutics site # 36

Denver, Colorado, 80218, United States

Location

EndoCeutics site # 52

Denver, Colorado, 80220, United States

Location

EndoCeutics site # 66

Danbury, Connecticut, 06810, United States

Location

EndoCeutics site # 42

Milford, Connecticut, 06460, United States

Location

EndoCeutics site # 57

West Hartford, Connecticut, 06117, United States

Location

EndoCeutics site # 61

Newark, Delaware, 19718, United States

Location

EndoCeutics site # 26

Jacksonville, Florida, 32207, United States

Location

EndoCeutics site # 60

Lake Worth, Florida, 33461, United States

Location

EndoCeutics site # 54

North Miami, Florida, 33161, United States

Location

EndoCeutics site # 56

Pinellas Park, Florida, 33781, United States

Location

EndoCeutics site # 23

Sandy Springs, Georgia, 30328, United States

Location

EndoCeutics site # 10

Meridian, Idaho, 83642, United States

Location

EndoCeutics site # 55

Wichita, Kansas, 67226, United States

Location

EndoCeutics site # 27

Baltimore, Maryland, 21285-6815, United States

Location

EndoCeutics site # 24

Omaha, Nebraska, 68131, United States

Location

EndoCeutics site # 50

Neptune City, New Jersey, 07753, United States

Location

EndoCeutics site # 33

Beachwood, Ohio, 44122, United States

Location

EndoCeutics site # 05

Cleveland, Ohio, 44122, United States

Location

EndoCeutics site # 47

Cleveland, Ohio, 44124, United States

Location

EndoCeutics site # 15

Columbus, Ohio, 43213, United States

Location

EndoCeutics site # 62

Providence, Rhode Island, 02930, United States

Location

EndoCeutics site # 64

Jackson, Tennessee, 38305, United States

Location

EndoCeutics site # 63

Memphis, Tennessee, 38120, United States

Location

EndoCeutics site # 53

San Antonio, Texas, 78205, United States

Location

EndoCeutics site # 51

Sandy City, Utah, 84070, United States

Location

EndoCeutics site # 09

West Jordan, Utah, 84088, United States

Location

EndoCeutics site # 03

Norfolk, Virginia, 23507, United States

Location

EndoCeutics site # 13

Calgary, Alberta, T2N 4L7, Canada

Location

EndoCeutics site # 06

Bathurst, New Brunswick, E2A 4X7, Canada

Location

EndoCeutics site # 59

Toronto, Ontario, M5B 1W8, Canada

Location

EndoCeutics site # 04

Drummondville, Quebec, J2B 7T1, Canada

Location

EndoCeutics site # 12

Montreal, Quebec, H4N 3C5, Canada

Location

EndoCeutics site # 02

Québec, Quebec, G1S 2L6, Canada

Location

EndoCeutics site # 01

Québec, Quebec, G1V 2L9, Canada

Location

EndoCeutics site # 18

Saint Romuald, Quebec, G6W 5M6, Canada

Location

EndoCeutics site # 08

Shawinigan, Quebec, G9N 2H6, Canada

Location

EndoCeutics site # 11

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (2)

• 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.

  PMID: 25511551 RESULT

• 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.

  PMID: 25968836 RESULT

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Results Point of Contact

• Title: Director of Data Analysis
• Organization: Endoceutics

celine.martel@endoceutics.com

418-653-0033

Study Officials

• David Archer, MD

  Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-06

Locations

US (32); CA (10)