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NCT01256684 Clinical Trial

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Vaginal Atrophy Clinical Trial

Official title:
DHEA Against Vaginal Atrophy (Placebo-controlled, Double-blind and Randomized Phase III Study of 3-month Intravaginal DHEA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01256684
Other study ID # ERC-231
Secondary ID
Status Completed
Phase Phase 3
First received December 3, 2010
Last updated May 1, 2013
Start date December 2010
Est. completion date November 2011

Study information
Verified date May 2013
Source EndoCeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date November 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo vaginal suppository
• DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
• DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.

Locations
Country Name City State
Canada EndoCeutics site # 06 Bathurst New Brunswick
Canada EndoCeutics site # 13 Calgary Alberta
Canada EndoCeutics site # 04 Drummondville Quebec
Canada EndoCeutics site # 12 Montreal Quebec
Canada EndoCeutics site # 01 Quebec City Quebec
Canada EndoCeutics site # 02 Quebec City Quebec
Canada EndoCeutics site # 08 Shawinigan Quebec
Canada EndoCeutics site # 11 Sherbrooke Quebec
Canada EndoCeutics site # 18 St-Romuald Quebec
United States EndoCeutics site # 27 Baltimore Maryland
United States EndoCeutics site # 45 Boynton Beach Florida
United States EndoCeutics site # 31 Charlottesville Virginia
United States EndoCeutics site # 05 Cleveland Ohio
United States EndoCeutics site # 15 Columbus Ohio
United States EndoCeutics site # 36 Denver Colorado
United States EndoCeutics site # 16 Durham North Carolina
United States EndoCeutics site # 26 Jacksonville Florida
United States EndoCeutics site # 22 Kalamazoo Michigan
United States EndoCeutics site # 25 Lincoln Nebraska
United States EndoCeutics site # 10 Meridian Idaho
United States EndoCeutics site # 42 Milford Connecticut
United States EndoCeutics site # 39 Montgomery Alabama
United States EndoCeutics site # 28 Moorestown New Jersey
United States EndoCeutics site # 44 New Brunswick New Jersey
United States EndoCeutics site # 19 New York New York
United States EndoCeutics site # 03 Norfolk Virginia
United States EndoCeutics site # 35 Pittsburg Pennsylvania
United States EndoCeutics site # 38 Renton Washington
United States EndoCeutics site # 21 Sacramento California
United States EndoCeutics site # 17 San Diego California
United States EndoCeutics site # 30 San Diego California
United States EndoCeutics site # 23 Sandy Springs Georgia
United States EndoCeutics site # 14 Tucson Arizona
United States EndoCeutics site # 07 Washington District of Columbia
United States EndoCeutics site # 09 West Jordan Utah

Sponsors (1)
Lead Sponsor Collaborator
EndoCeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Co-primary endpoint: change from baseline over time of vaginal cell maturation (percentage of parabasal and superficial cells). 12 weeks No
Primary Co-primary endpoint: change from baseline over time of vaginal pH. 12 weeks No
Primary Co-primary endpoint: change from baseline over time of self-assessment of symptoms of vulvar/vaginal atrophy. 12 weeks No
Secondary Local tolerance to intravaginal administration of DHEA. 12 weeks Yes
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