Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Bazedoxifene/Conjugated Estrogen
Outcome Measures for this Clinical Trial
Primary Measures
- Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Secondary Measures
- 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.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234819
Study ID Number: 3115A1-305
ClinicalTrials.gov Identifier: NCT00234819
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00234819
