Vasomotor Symptoms Associated With Menopause
Conditions
Keywords
Menopause
Brief summary
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago * Intact uterus * Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week
Exclusion criteria
* History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders * History of active presence of stroke, TIA, heart attack or ischemic heart disease * History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards. | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire. | — |
Countries
United States
Outcome results
None listed