Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
This is an unblinded study to be conducted at a single research center, San Diego Sexual
 Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene
 daily for twenty weeks. After the informed consent is signed, a baseline physical
 examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina,
 will be performed. Physical examination and vulvoscopy with detailed photography of the
 vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20
 weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva,
 vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4
 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session
 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily
 administration of 60 mg ospemifene.
Ospemifene is indicated for post-menopausal women diagnosed with vulvar vaginal atrophy (VVA)
 and dyspareunia. While ospemifene clinically significantly reduces pain associated with
 dyspareunia, there has been little prospective documentation using vulvoscopy with detailed
 photography of the visible changes to the vulva, vestibule and vaginal region with daily
 administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. This
 study will include a total of 6 prospective photographic sessions of the vulva, vestibule and
 vagina over the 20 weeks administration of 60 mg ospemifene in the study. Comparisons will be
 made of baseline photography (vulvoscopy session 0) with photography at 4 weeks (vulvoscopy
 session 1), 8 weeks (vulvoscopy session 2), 12 weeks (vulvoscopy session 3), 16 weeks
 (vulvoscopy session 4) and 20 weeks (vulvoscopy session 5).

 Currently there have been limited prospective studies using vulvoscopy with detailed
 photography demonstrating visible changes to the vulva, vestibule and vagina following oral
 administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia.
 Information regarding visible changes to the vulva, vestibule and vagina may be very
 important to the patient and to the health care provider to best understand the beneficial
 effects of ospemifene and to ensure patient compliance with treatment.
Inclusion Criteria:

 1. Subject provides written informed consent and HIPAA authorization before any study
 procedures are conducted

 2. Subject is female

 3. Subject is aged 21-80 years

 4. Subject has a body mass index (BMI) < 37 kg/m2

 5. Subject is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks
 after a bilateral salpingo-oophorectomy prior to natural menopause subjects with
 hysterectomy only must have a serum Follicle Stimulating Hormone > 40
 milli-International unit /mL

 6. Subject has vulvovaginal atrophy with dyspareunia

 7. Subject has had a normal mammogram within the last 6 months

 8. Subject has normal pap smear within last 6 months

 9. Subject has an endometrial stripe ≤ 4 mm within the last 6 months if she has a uterus

 10. Subject agrees to comply with the study procedures and visits.

 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.