Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Hyperplasia; Osteoporosis
Intervention: Bazedoxifene/Conjugated Estrogen (Drug); Placebo (Other)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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 postmenopausal women.
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 yearFor the osteoporosis substudy, bone mineral density of the spine and hip as measured at screening and 1 year.
Secondary outcome: Uterine bleeding/spotting and breast pain at screening and through 1 year (by diary)
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Upland, California 91786, United States
Inverness, Florida 34452, United States
West Palm Beach, Florida 33409, United States
Decatur, Georgia 30033, United States
Honolulu, Hawaii 96814, United States
Lexington, Kentucky 40536-0293, United States
Billings, Montana 59102, United States
Eugene, Oregon 97401, United States
Pittsburgh, Pennsylvania 15206, United States
Additional Information
Starting date: September 2005
Ending date: August 2008
Last updated: December 21, 2007
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