Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasomotor Symptoms Associated With Menopause
Intervention: Bazedoxifene/Conjugated Estrogen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Secondary outcome: 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 64 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Phoenix, Arizona 85105, United States
North Port Richey, Florida 34652, United States
Ft. Myers, Florida 33916, United States
Scarborough, Maine 04074, United States
Albuquerque, New Mexico 87102, United States
Winston-Salem, North Carolina 27103, United States
Pottstown, Pennsylvania 19464, United States
Additional Information
Starting date: October 2005
Ending date: February 2007
Last updated: December 19, 2007
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