NCT00630539 - A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women | Biotech Hunter

Enrollment

126

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

February 29, 2008

Conditions

AtrophyVaginal Diseases

Interventions

DRUG

Placebo

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

DRUG

Ospemifene 5 mg

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

DRUG

Ospemifene 15 mg

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

DRUG

Ospemifene 30 mg

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).