Conditions: Atrophy Vaginal Diseases
Keywords: Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 126
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Detailed description:

Arms:
arm 1: Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks arm 2: Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks arm 3: Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks arm 4: Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Interventions: intervention 1: Placebo intervention 2: Ospemifene 5 mg intervention 3: Ospemifene 15 mg intervention 4: Ospemifene 30 mg
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: 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). intervention 4: 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).

Protocol document: