Conditions: Atrophy Vaginal Diseases
Keywords: Urogenital atrophy Menopausal symptoms Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. arm 2: Placebo will be taken once daily, in the morning, with food for 52 weeks.

Interventions: intervention 1: Ospemifene 60 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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)

Protocol document: