Study Evaluating Safety and Efficacy of 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/Conjugate Estrogens (CE) (Drug); Raloxifene (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
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 Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
Secondary outcome: To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Generally healthy, postmenopausal women aged 40 - 75 years inclusive
- Intact uterus
- Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12
consecutive months before screening
Exclusion Criteria:
- A history or active presence of thrombophlebitis, thrombosis or thromboembolic
disorders
- A history or active presence of cerebrovascular accident, stroke, or transient
ischemic attack
- A history or active presence of malignancy, or treatment for malignancy, within the
previous 10 years
Additional criteria applies.
Locations and Contacts
Additional Information
Starting date: April 2002
Ending date: January 2006
Last updated: May 9, 2008
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