Status:
COMPLETED
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Lead Sponsor:
Pfizer
Conditions:
Endometrial Hyperplasia
Osteoporosis
Eligibility:
FEMALE
40-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in p...
Eligibility Criteria
Inclusion
- Generally healthy, postmenopausal women, aged 40 to less than 65 years
- Intact uterus
- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL.
Exclusion
- Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
- A history or active presence of clinically important medical disease
- Malabsorption disorders
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
1083 Patients enrolled
Trial Details
Trial ID
NCT00242710
Start Date
September 1 2005
End Date
September 1 2008
Last Update
December 20 2013
Active Locations (9)
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1
Pfizer Investigational Site
Upland, California, United States, 91786
2
Pfizer Investigational Site
Inverness, Florida, United States, 34452
3
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
4
Pfizer Investigational Site
Decatur, Georgia, United States, 30033