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

Phase 3

Completed

• Conditions: Endometrial Hyperplasia; Osteoporosis
• Interventions: Drug: Bazedoxifene/Conjugate Estrogens (CE); Drug: Placebo; Drug: Raloxifene

• Registration Number: NCT00675688
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-09
• Last Update Submitted: 2008-05-09
• Study First Posted: 2008-05-12
• Last Update Posted: 2008-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3544

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Bazedoxifene/Conjugate Estrogens (CE)	-
C	Placebo	-
B	Raloxifene	-

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.	one year

Secondary Outcome Measures

Name	Time	Method
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.	one year