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 (Adult, Senior)
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 DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Côté I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur É; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.

Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.

Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dubé 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.


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:	February 19, 2016
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

ClinicalTrials.gov processed this record on September 23, 2016