Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

Exclusion Criteria

• •has a hypersensitivity to DHEA;
• •has used prasterone in the past 6 months;
• •has documented or suspected breast cancer;
• •has undiagnosed genital bleeding:
• •has clinically significant findings on physical examination;
• •has uncontrolled hypertension;
• •has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
• •is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet;
• •is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy);
• •is currently using a selective estrogen receptor modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month;
• •has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
• •has received an investigational drug within 30 days prior to signing consent;
• •has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.