DHEA Against Vaginal Atrophy - Safety Study of 12 Months - Full Text View

Purpose

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Condition	Intervention	Phase
Vaginal Atrophy	Drug: DHEA	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	DHEA Against Vaginal Atrophy - Safety Study of 12 Months

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:

Change from baseline over time of clinical safety data: adverse event (AE) reporting, vital signs, physical examination findings, gynecological examination findings, clinical laboratory tests, endometrial biopsy, mammography and Pap smear. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline over time of vaginal pH. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]


Enrollment:	530
Study Start Date:	December 2010
Study Completion Date:	December 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DHEA 0.5% DHEA (intravaginal)	Drug: DHEA Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 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 (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.
Willing to have endometrial biopsy at screening and end of study (Week 52).

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256671

Show 43 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. doi: 10.1097/gme.0b013e31819e8e2d.

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. doi: 10.1097/gme.0b013e31819e85c6.

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. doi: 10.1097/gme.0b013e31819e8930.

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. doi: 10.3109/09513590903511547.

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. doi: 10.1016/j.jsbmb.2008.06.003. 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. doi: 10.1016/S0079-6123(10)82004-7.


Responsible Party:	EndoCeutics Inc.
ClinicalTrials.gov Identifier:	NCT01256671 History of Changes
Other Study ID Numbers:	ERC-230
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 Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015