Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspare… (NCT02784613) | Clinical Trial Compass
CompletedPhase 4
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
United States10 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
✓. Subject is female
✓. Subject is aged 21-80 years
✓. Subject has a body mass index (BMI) \< 37 kg/m2
✓. 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
✓. Subject has vulvovaginal atrophy with dyspareunia
✓. Subject has had a normal mammogram within the last 6 months
✓. Subject has normal pap smear within last 6 months
Exclusion criteria
✕. Subject has a hypersensitivity to any of the ingredients of ospemifene
✕
What they're measuring
1
Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography
✕. Subject has documented or suspected breast cancer, history of heart attack or stroke
✕. Subject has clinically significant findings on physical examination
✕. Subject has uncontrolled hypertension
✕. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study
✕. 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
✕. Subject is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy)