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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis | Clinical Trials | Clareo Health

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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

NCT00808132•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Eligibility

Age

40 - 64 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
•At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL
•Intact Uterus

Exclusion Criteria

•Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
•A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.

Locations (178)

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Mobile, Alabama, United States

Pfizer Investigational Site

Chandler, Arizona, United States

Pfizer Investigational Site

Glendale, Arizona, United States

Pfizer Investigational Site

Mesa, Arizona, United States

Pfizer Investigational Site

Peoria, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

Tucson, Arizona, United States

Pfizer Investigational Site

Tucson, Arizona, United States

Key Dates

Start Date

January 1, 2009

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

April 8, 2014

Enrollment

1,886

ACTUAL participants

Conditions

MenopauseOsteoporosis

Interventions

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

DRUG

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

DRUG

bazedoxifene 20 mg

DRUG

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

DRUG

Placebo

DRUG

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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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: April 8, 2014Data 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 The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Vaginal Changes After CO2 Laser

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project