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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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

NCT00242710•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 - 65 years

Sex

FEMALE

Healthy Volunteers

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 (9)

Pfizer Investigational Site

Upland, California, United States

Pfizer Investigational Site

Inverness, Florida, United States

Pfizer Investigational Site

West Palm Beach, Florida, United States

Pfizer Investigational Site

Decatur, Georgia, United States

Pfizer Investigational Site

Honolulu, Hawaii, United States

Pfizer Investigational Site

Lexington, Kentucky, United States

Pfizer Investigational Site

Billings, Montana, United States

Pfizer Investigational Site

Eugene, Oregon, United States

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

September 1, 2005

Primary Completion Date

September 1, 2008

Completion Date

September 1, 2008

Last Updated

December 20, 2013

Enrollment

1,083

ACTUAL participants

Conditions

Endometrial HyperplasiaOsteoporosis

Interventions

Bazedoxifene/Conjugated Estrogen

DRUG

Bazedoxifene/Conjugated Estrogen

DRUG

CE 0.45 mg/MPA 1.5mg

DRUG

Placebo

OTHER

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

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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: December 20, 2013Data 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 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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