Irwin Goldstein, MD
Menopause. 26(9):994-1001, September 2019
This is a phase 3 pivotal trial of ospemifene versus placebo in women in menopause with moderate to severe vaginal dryness, a symptom of GSM. On physical examination, such women commonly have vulvar, vestibular and vaginal atrophy. This study, for the first time, utilized vulvar vestibular photography to objectively document changes in genital health. There were no changes noted in photography on placebo, however active therapy with a SERM resulted in regrowth of labia minora, normalization of the urethral gland prominence, resolution of the pallor and erythema of the vestibule and visualization of vestibular moisture. Visual assessment of genital health in such patients should be utilized in future trials.