Conditions: Atrophy Vaginal Diseases
Keywords: Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms Vaginal atrophy Urogenital atrophy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 919
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Detailed description:

Arms:
arm 1: Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. arm 2: Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Interventions: intervention 1: Ospemifene 60 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed intervention 2: oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Protocol document: