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

• Status: Completed
• Trial end date: 2017-07-05
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi
• Treatments: Tamoxifen

Criteria

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).