NCT00276094

A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 826 (actual)
• Sponsor: Shionogi · Industry
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Conditions

• Atrophy
• Vaginal Diseases

Interventions

Type	Name	Description
DRUG	Ospemifene 30 mg	1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUG	Ospemifene 60 mg	1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUG	Placebo	1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
DRUG	Nonhormonal vaginal lubricant	Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Timeline

• Start date: 2006-01-01
• Completion: 2007-12-01
• First posted: 2006-01-12
• Last updated: 2013-06-28
• Results posted: 2013-06-28