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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00242710 |
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 postmenopausal women.
Condition | Intervention | Phase |
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Endometrial Hyperplasia Osteoporosis |
Drug: Bazedoxifene/Conjugated Estrogen Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women |
Estimated Enrollment: | 870 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
BZA 20mg/CE 0.625
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Drug: Bazedoxifene/Conjugated Estrogen
BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
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Arm 2: Active Comparator
BZA 20mg/CE 0.45
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Drug: Bazedoxifene/Conjugated Estrogen
BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
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Arm 3: Active Comparator
CE 0.45mg/MPA1.5mg
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Drug: Bazedoxifene/Conjugated Estrogen
BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
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Arm 4: Placebo Comparator
Placebo
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Other: Placebo
Placebo
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Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Upland, California, United States, 91786 | |
United States, Florida | |
Inverness, Florida, United States, 34452 | |
West Palm Beach, Florida, United States, 33409 | |
United States, Georgia | |
Decatur, Georgia, United States, 30033 | |
United States, Hawaii | |
Honolulu, Hawaii, United States, 96814 | |
United States, Kentucky | |
Lexington, Kentucky, United States, 40536-0293 | |
United States, Montana | |
Billings, Montana, United States, 59102 | |
United States, Oregon | |
Eugene, Oregon, United States, 97401 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15206 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3115A1-304 |
Study First Received: | October 18, 2005 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00242710 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Endometrium Uterus Menopause |
Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Uterine Diseases Bone Diseases, Metabolic Bone Diseases |
Hormones Genital Diseases, Female Hyperplasia Estrogens, Conjugated (USP) Musculoskeletal Diseases Menopause Endometrial Hyperplasia |
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Osteoporosis Uterine Diseases Bone Diseases, Metabolic Bone Diseases Hormones |
Pharmacologic Actions Genital Diseases, Female Hyperplasia Estrogens, Conjugated (USP) Pathologic Processes Musculoskeletal Diseases Endometrial Hyperplasia |