NCT00566982

A Clinical Study to Evaluate the Safety of Ospemifene

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Shionogi · Industry
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Conditions

• Atrophy
• Vaginal Diseases

Interventions

Type	Name	Description
DRUG	Ospemifene 60 mg	60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
DRUG	Placebo	Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-12-04
• Last updated: 2018-05-18
• Results posted: 2013-06-28