Status:
COMPLETED
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Lead Sponsor:
Pfizer
Conditions:
Menopause
Osteoporosis
Eligibility:
FEMALE
40-64 years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) a...
Eligibility Criteria
Inclusion
- Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL
- Intact Uterus
Exclusion
- Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
- A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1886 Patients enrolled
Trial Details
Trial ID
NCT00808132
Start Date
January 1 2009
End Date
February 1 2011
Last Update
April 8 2014
Active Locations (178)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
3
Pfizer Investigational Site
Chandler, Arizona, United States, 85225
4
Pfizer Investigational Site
Glendale, Arizona, United States, 85308