Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA

Exclusion Criteria

• •1. Subject has a hypersensitivity to any of the ingredients of ospemifene
• •2. Subject has used ospemifene in the past
• •3. Subject has documented or suspected breast cancer, history of heart attack or stroke
• •4. Subject has clinically significant findings on physical examination
• •5. Subject has uncontrolled hypertension
• •6. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study
• •7. Subject 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
• •8. Subject is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy)
• •9. Subject is currently using a Selective Estrogen Receptor Modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month
• •10. Subject currently using itraconazole, ketoconazole, digitalis or alkaloids heparin or strong cytochrome P 450 3A4 inhibitors
• •11. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week
• •12. Subject has received an investigational drug within 30 days prior to signing consent
• •13. Subject 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.