Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Active, not recruiting
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 vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing
postmenopausal female population, and the most common symptom is dyspareunia. Vaginal
estrogen is the most common treatment for VVA, but it only marginally improves overall
sexual function, and many women and clinicians avoid using it because of the risks of
exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen
receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and
has shown improvements in sexual health that are superior to vaginal estrogen. 104 women
will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of
0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The
improvements in sexual health and VVA symptom severity will be compared in each group. This
study will help determine if ospemifene is a better treatment medication than conjugated
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