DHEA Against Vaginal Atrophy - 3-Month Efficacy Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Vaginal Atrophy	Drug: Placebo Drug: DHEA	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

Resource links provided by NLM:

Drug Information available for: Prasterone

U.S. FDA Resources

Further study details as provided by EndoCeutics Inc.:

Primary Outcome Measures:

Co-primary endpoint: change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Co-primary endpoint: change from baseline over time of vaginal pH. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Co-primary endpoint: change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tolerance to intravaginal administration of DHEA. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	255
Study Start Date:	December 2010
Study Completion Date:	November 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo vaginal suppository
Experimental: 0.25% DHEA	Drug: DHEA Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. Other Name: Prasterone, Dehydroepiandrosterone, Vaginorm
Experimental: 0.5% DHEA	Drug: DHEA Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. Other Name: Prasterone, Dehydroepiandrosterone, Vaginorm

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

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.

Main 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256684

Show 35 Study Locations

Sponsors and Collaborators

EndoCeutics Inc.

Investigators

Principal Investigator:

David F Archer, MD

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

More Information

Publications:

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté 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.

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté 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.

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Bérubé R, Bélanger 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.

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté 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.

Labrie F, Cusan L, Gomez JL, Côté I, Bérubé R, Bélanger P, Martel C, Labrie C. Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol. 2008 Sep;111(3-5):178-94. Epub 2008 Jun 12. Erratum in: J Steroid Biochem Mol Biol. 2008 Nov;112(1-3):169.

Labrie F. DHEA, important source of sex steroids in men and even more in women. Prog Brain Res. 2010;182:97-148.

Responsible Party:	EndoCeutics Inc.
ClinicalTrials.gov Identifier:	NCT01256684 History of Changes
Other Study ID Numbers:	ERC-231
Study First Received:	December 3, 2010
Last Updated:	May 1, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by EndoCeutics Inc.:

Vulvar/vaginal atrophy
Atrophic Vaginitis
Dehydroepiandrosterone
DHEA

Prasterone
Vaginorm
Menopause

Additional relevant MeSH terms:

Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
Adjuvants, Immunologic

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013