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Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

NCT00675688•Wyeth is now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

FEMALE

Healthy Volunteers

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.

Key Dates

Start Date

April 1, 2002

Primary Completion Date

January 1, 2006

Completion Date

January 1, 2006

Last Updated

May 12, 2008

Enrollment

3,544

ACTUAL participants

Conditions

Endometrial HyperplasiaOsteoporosis

Interventions

Bazedoxifene/Conjugate Estrogens (CE)

DRUG

Raloxifene

DRUG

Placebo

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE2

Uterine Preservation Via Lifestyle Transformation

NCT05903131

Endometrial HyperplasiaGrade 1 Endometrial Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Uterine Preservation Via Lifestyle Transformation

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