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

NCT ID: NCT00808132

Last Updated: 2014-04-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Menopause Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

bazedoxifene 20 mg/conjugated estrogens 0.45 mg

Group Type EXPERIMENTAL

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

Intervention Type DRUG

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.

2

bazedoxifene 20 mg/conjugated estrogens 0.625 mg

Group Type EXPERIMENTAL

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

Intervention Type DRUG

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.

3

bazedoxifene 20 mg

Group Type EXPERIMENTAL

bazedoxifene 20 mg

Intervention Type DRUG

One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

4

Prempro

Group Type ACTIVE_COMPARATOR

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

Intervention Type DRUG

One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One capsule, placebo (over-encapsulated), once a day for one year.

Interventions

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bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.

Intervention Type DRUG

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.

Intervention Type DRUG

bazedoxifene 20 mg

One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

Intervention Type DRUG

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.

Intervention Type DRUG

Placebo

One capsule, placebo (over-encapsulated), once a day for one year.

Intervention Type DRUG

Other Intervention Names

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Prempro

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Upland, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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New London, Connecticut, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Crystal River, Florida, United States

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Daytona Beach, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Springs, Florida, United States

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New Port Richey, Florida, United States

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Pinellas Park, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Rockford, Illinois, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Lousiville, Kentucky, United States

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Bangor, Maine, United States

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Ann Arbor, Michigan, United States

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Paw Paw, Michigan, United States

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Port Jefferson, New York, United States

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Charlotte, North Carolina, United States

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Kernersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Minot, North Dakota, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Hilton Head Island, South Carolina, United States

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Watertown, South Dakota, United States

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Chattanooga, Tennessee, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Pleasant Grove, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Randwick, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Perth, Western Australia, Australia

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Santiago, RM, Chile

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Aalborg, , Denmark

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Ballerup Municipality, , Denmark

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Vejle, , Denmark

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Kuopio, , Finland

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Oulu, , Finland

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Békéscsaba, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Nyíregyháza, , Hungary

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Tatabánya, , Hungary

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D.F, Mexico, Mexico

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Dunedin, NZ, New Zealand

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Wellington, NZ, New Zealand

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Christchurch, , New Zealand

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Ålesund, Norway, Norway

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Hamar, , Norway

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Poznan, Poland, Poland

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Wroclaw, Poland, Poland

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Lublin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Countries

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United States Argentina Australia Chile Colombia Denmark Finland Hungary Mexico New Zealand Norway Poland

References

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Pinkerton JV, Harvey JA, Lindsay R, Pan K, Chines AA, Mirkin S, Archer DF; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014 Feb;99(2):E189-98. doi: 10.1210/jc.2013-1707. Epub 2014 Jan 17.

Reference Type DERIVED
PMID: 24438370 (View on PubMed)

Pinkerton JV, Harvey JA, Pan K, Thompson JR, Ryan KA, Chines AA, Mirkin S. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):959-968. doi: 10.1097/AOG.0b013e31828c5974.

Reference Type DERIVED
PMID: 23635731 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3115A1-3307&StudyName=Study%20Evaluating%20The%20Effects%20Of%20Bazedoxifene/Conjugated%20Estrogens%20On%20Endometrial%20Safety%20And%20Postmenopausal%20Osteoporosis

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2311009

Identifier Type: -

Identifier Source: secondary_id

3115A1-3307

Identifier Type: -

Identifier Source: org_study_id

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