Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Inclusion Criteria:

• Naturally or surgically menopausal
• Moderate or severe symptoms of vaginal atrophy
• 5% or fewer superficial cells in maturation index of vaginal smear
• Vaginal pH greater than 5.0
• Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion Criteria:

• Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
• Current vaginal infection requiring medication
• Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

• Previous participation in any other ospemifene study