NCT00276094 - A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women | Biotech Hunter

Enrollment

826

Participants

Timeline

Start Date

January 31, 2006

Study Completion Date

December 31, 2007

Conditions

AtrophyVaginal Diseases

Interventions

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.