Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP); Raloxifene Hydrochloride

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.