Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Status:
Completed
Trial end date:
2017-04-17
Target enrollment:
Participant gender:
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.