Topical DHEA Against Vaginal Atrophy

NCT01846442 | Completed Phase 3 Results

• 1 other identifier: ERC-210
• Study Type: interventional
• Target: 218
• Locations: 2 countries
• Sites: 8

Brief Summary

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

Conditions

Vaginal Atrophy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)

  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

• Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)

  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

• Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.

  A pH strip was applied directly to the lateral wall of the vagina using forceps. 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

• Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia

  The severity of dyspareunia was evaluated by a questionnaire. 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 (4)

• Change From Baseline to Week 12 of Vaginal Secretions

  Baseline and Week 12

• Change From Baseline to Week 12 of Vaginal Epithelial Integrity

  Baseline and Week 12

• Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness

  Baseline and Week 12

• Change From Baseline to Week 12 of Vaginal Color

  Baseline and Week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

0.25% DHEA

EXPERIMENTAL

Drug: DHEA (0.25%)

0.5% DHEA

EXPERIMENTAL

Drug: DHEA (0.5%)

1.0% DHEA

EXPERIMENTAL

Drug: DHEA (1.0%)

Interventions

Placebo DRUG

Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.

Also known as: Prasterone, Dehydroepiandrosterone

Placebo

DHEA (0.25%) 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

DHEA (0.5%) DRUG

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

Also known as: Prasterone, Dehydroepiandrosterone

0.5% DHEA

DHEA (1.0%) DRUG

Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

Also known as: Prasterone, Dehydroepiandrosterone

1.0% 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 having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
• Women having a vaginal pH above 5
• Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

You may not qualify if:

• Undiagnosed abnormal genital bleeding
• Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
• The administration of any investigational drug within 30 days of screening visit
• Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
• Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry

Sponsors & Collaborators

• EndoCeutics Inc.: lead

Study Sites (8)

EndoCeutics site # 05

Cleveland, Ohio, 44122, United States

Location

EndoCeutics site # 03

Norfolk, Virginia, 23507, United States

Location

EndoCeutics site # 10

Montreal, Quebec, H1T 1P6, Canada

Location

EndoCeutics site # 09

Montreal, Quebec, H3A 1A1, Canada

Location

EndoCeutics site # 08

Shawinigan, Quebec, G9N 2H6, Canada

Location

EndoCeutics site # 11

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

EndoCeutics site # 02

Québec, G1S 2L6, Canada

Location

EndoCeutics site # 01

Québec, G1V 4G2, Canada

Location

Related Publications (9)

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berube R, Belanger P, Berger L, Gilbert L, Martel C, Balser J. Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration. Menopause. 2009 Sep-Oct;16(5):897-906. doi: 10.1097/gme.0b013e31819e8930.

  PMID: 19436226 RESULT

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Menopause. 2009 Sep-Oct;16(5):907-22. doi: 10.1097/gme.0b013e31819e8e2d.

  PMID: 19436225 RESULT

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.

  PMID: 19424093 RESULT

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Martel C, Balser J. High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy. Gynecol Endocrinol. 2010 Jul;26(7):524-32. doi: 10.3109/09513590903511547.

  PMID: 20459349 RESULT

• Labrie F, Archer DF, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric. 2011 Apr;14(2):282-8. doi: 10.3109/13697137.2010.535226. Epub 2011 Jan 18.

  PMID: 21244215 RESULT

• Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Gilbert L, Martel C, Balser J. Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women. J Sex Med. 2014 Jul;11(7):1766-85. doi: 10.1111/jsm.12517. Epub 2014 Apr 28.

  PMID: 24774442 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

• Labrie F. Intravaginal DHEA, by a strictly local action, exerts beneficial effects on both vaginal atrophy symptoms and sexual dysfunction. Horm Mol Biol Clin Investig. 2010 Dec 1;4(1):499-507. doi: 10.1515/HMBCI.2010.064.

  PMID: 25961226 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 Scholl, 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 1, 2013
• First Posted: May 3, 2013
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 29, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-07

Locations

US (2); CA (6)