Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
NCT ID: NCT00242710
Last Updated: 2013-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1083 participants
INTERVENTIONAL
2005-09-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
BZA 20mg/CE 0.625
Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Arm 2
BZA 20mg/CE 0.45
Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Arm 3
CE 0.45mg/MPA1.5mg
CE 0.45 mg/MPA 1.5mg
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Arm 4
Placebo
Placebo
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Interventions
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Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
CE 0.45 mg/MPA 1.5mg
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Placebo
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* Intact uterus
* At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL.
Exclusion Criteria
* A history or active presence of clinically important medical disease
* Malabsorption disorders
40 Years
65 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Inverness, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Honolulu, Hawaii, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Billings, Montana, United States
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3115A1-304
Identifier Type: -
Identifier Source: org_study_id
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