Conditions: Atrophy Vaginal Diseases
Keywords: Urogenital atrophy Vaginal atrophy Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 826
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Detailed description:

Arms:
arm 1: Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 2: Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm 3: Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

Interventions: intervention 1: Ospemifene 30 mg intervention 2: Ospemifene 60 mg intervention 3: Placebo intervention 4: Nonhormonal vaginal lubricant
Intervention descriptions: intervention 1: 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 2: 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 3: 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 4: Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

Protocol document: