DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

NCT01256684 | Completed Phase 3 Results DMC

• 1 other identifier: ERC-231
• Study Type: interventional
• Target: 255
• Locations: 2 countries
• Sites: 33

Brief Summary

The purpose of this Phase III trial is to confirm 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 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.

  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 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.

  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 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

Secondary Outcomes (5)

• Change From Baseline to Week 12 in Severity of Vaginal Dryness

  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; daily dosing with one suppository for 12 weeks.

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 (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.

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 (33)

EndoCeutics site # 39

Montgomery, Alabama, 36117, United States

Location

EndoCeutics site # 14

Tucson, Arizona, 85712, United States

Location

EndoCeutics site # 21

Sacramento, California, 95821, United States

Location

EndoCeutics site # 30

San Diego, California, 92108, United States

Location

EndoCeutics site # 17

San Diego, California, 92120, United States

Location

EndoCeutics site # 36

Denver, Colorado, 80218, United States

Location

EndoCeutics site # 42

Milford, Connecticut, 06460, United States

Location

EndoCeutics site # 45

Boynton Beach, Florida, 33472, United States

Location

EndoCeutics site # 26

Jacksonville, Florida, 32207, United States

Location

EndoCeutics site # 23

Sandy Springs, Georgia, 30328, United States

Location

EndoCeutics site # 10

Meridian, Idaho, 83642, United States

Location

EndoCeutics site # 27

Baltimore, Maryland, 21285-6815, United States

Location

EndoCeutics site # 22

Kalamazoo, Michigan, 49009, United States

Location

EndoCeutics site # 25

Lincoln, Nebraska, 68510, United States

Location

EndoCeutics site # 28

Moorestown, New Jersey, 08057, United States

Location

EndoCeutics site # 44

New Brunswick, New Jersey, 08901, United States

Location

EndoCeutics site # 19

New York, New York, 10016, United States

Location

EndoCeutics site # 16

Durham, North Carolina, 27713, United States

Location

EndoCeutics site # 05

Cleveland, Ohio, 44122, United States

Location

EndoCeutics site # 15

Columbus, Ohio, 43213, United States

Location

EndoCeutics site # 35

Pittsburgh, Pennsylvania, 15206, United States

Location

EndoCeutics site # 09

West Jordan, Utah, 84088, United States

Location

EndoCeutics site # 31

Charlottesville, Virginia, 22903, 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 # 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 (3)

• 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.

  PMID: 25734980 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

• 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.

  PMID: 26972555 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 F 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: December 3, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 26, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-05

Locations

US (24); CA (9)