Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Condition: Vulvovaginal Atrophy; Dyspareunia
MeSH terms: Dyspareunia; Atrophy
Intervention: Ospemifene
Intervention description: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.