Topical DHEA Against Vaginal Atrophy

Vaginal Atrophy Clinical Trial

Official title:

Topical DHEA Against Vaginal Atrophy (3-Month Placebo-Controlled Double-Blind Randomized Phase III Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846442
• Other study ID #: ERC-210
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2013
• Last updated: May 2, 2013
• Start date: June 2007
• Est. completion date: October 2008

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 study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA in postmenopausal women suffering from vaginal atrophy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• Placebo
Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
• DHEA (0.25%)
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
• DHEA (0.5%)
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
• DHEA (1.0%)
Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.

Locations

Country	Name	City	State
Canada	EndoCeutics site # 09	Montreal	Quebec
Canada	EndoCeutics site # 10	Montreal	Quebec
Canada	EndoCeutics site # 01	Quebec
Canada	EndoCeutics site # 02	Quebec
Canada	EndoCeutics site # 08	Shawinigan	Quebec
Canada	EndoCeutics site # 11	Sherbrooke	Quebec
United States	EndoCeutics site # 05	Cleveland	Ohio
United States	EndoCeutics site # 03	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
EndoCeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

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 sexu — 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 — 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 — 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 dehydr — View Citation

Labrie F, Archer DF, 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 highly efficient treatme — 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; maturation value)		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 in the moderate to severe symptom of vaginal atrophy identified by the subject as most bothersome to her.		12 weeks	No
Secondary	Local tolerance to intravaginal administration of DHEA.		12 weeks	Yes
Secondary	Change from baseline over time in quality of life evaluated by the Menopause Specific Quality of Life (MENQOL) questionnaire.		12 weeks	No
Secondary	Change from baseline over time in sexual function evaluated by the Abbreviated Sexual Function (ASF), the Sexual Concern (SC) and the Psychological General Well-Being (PGWB) questionnaires.		12 weeks	No