Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.

Inclusion Criteria:

• Subject is postmenopausal.
• Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

• Subject has clinically significant abnormal findings in the physical examination.
• Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2
• Subject has uncontrolled hypertension.
• Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
• Subject has uterine/vaginal bleeding of unknown origin.
• Subject has a vaginal infection requiring medication (may be treated and be eligible for study).