NCT00566982 - A Clinical Study to Evaluate the Safety of Ospemifene | Biotech Hunter

Enrollment

426

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions

AtrophyVaginal Diseases

Interventions

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)