Clinical trial NCT00808132: Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Osteoporosis
Keywords: Postmenopausal Women
Bazedoxifene/Conjugated Estrogens
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 1886
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
timeFrame: Month 12
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
timeFrame: Baseline, Month 6, Month 12
measure: Percentage of Participants With Cumulative Amenorrhea: Main Study
timeFrame: Day 1 up to Day 364
measure: Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
timeFrame: Baseline, Month 6, 12
measure: Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
timeFrame: Baseline
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
timeFrame: Baseline, Month 3
measure: Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
timeFrame: Baseline
measure: Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
timeFrame: Baseline, Month 3
measure: Percentage of Participants With Uterine Bleeding
timeFrame: Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Other outcomes:
measure: Percentage of Participants With Breast Tenderness
timeFrame: Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Crystal River
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Deland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
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city: New Port Richey
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state: Florida
city: Pinellas Park
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city: Sunrise
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facility: Pfizer Investigational Site
state: Florida
city: Tampa
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facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
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facility: Pfizer Investigational Site
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city: Atlanta
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facility: Pfizer Investigational Site
state: Georgia
city: Augusta
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facility: Pfizer Investigational Site
state: Georgia
city: Decatur
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facility: Pfizer Investigational Site
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city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Savannah
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facility: Pfizer Investigational Site
state: Georgia
city: Savannah
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facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Idaho Falls
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facility: Pfizer Investigational Site
state: Idaho
city: Meridian
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facility: Pfizer Investigational Site
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city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Rockford
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facility: Pfizer Investigational Site
state: Illinois
city: South Bend
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facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
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facility: Pfizer Investigational Site
state: Kansas
city: Lexington
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facility: Pfizer Investigational Site
state: Kentucky
city: Lousiville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bangor
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Ann Arbor
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facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Paw Paw
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Brooklyn Center
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facility: Pfizer Investigational Site
state: Minnesota
city: Chaska
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facility: Pfizer Investigational Site
state: Minnesota
city: Robbinsdale
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state: Minnesota
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
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facility: Pfizer Investigational Site
state: Montana
city: Billings
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state: Montana
city: Lincoln
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state: Nebraska
city: Omaha
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facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
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facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
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facility: Pfizer Investigational Site
state: Nevada
city: North Las Vegas
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facility: Pfizer Investigational Site
state: Nevada
city: Reno
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state: Nevada
city: Lebanon
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state: New Hampshire
city: Brick
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facility: Pfizer Investigational Site
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city: New Brunswick
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city: Albuquerque
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city: Albuquerque
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state: New York
city: Port Jefferson
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city: Charlotte
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facility: Pfizer Investigational Site
state: North Carolina
city: Kernersville
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city: Winston-Salem
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city: Fargo
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city: Minot
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city: Cincinnati
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city: Cleveland
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city: Cleveland
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city: Columbus
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city: Dayton
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city: Englewood
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city: Mayfield Heights
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city: Eugene
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city: Medford
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city: Portland
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city: Erie
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city: Hopwood
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city: Jenkintown
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state: Pennsylvania
city: Johnstown
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Pittsburgh
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state: Pennsylvania
city: West Reading
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state: Pennsylvania
city: Wexford
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state: Pennsylvania
city: Warwick
country: United States
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state: Rhode Island
city: Bluffton
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facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
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state: South Carolina
city: Hilton Head Island
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
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state: South Dakota
city: Sioux Falls
country: United States
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state: South Dakota
city: Watertown
country: United States
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state: South Dakota
city: Chattanooga
country: United States
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state: Tennessee
city: Jackson
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Memphis
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state: Tennessee
city: Nashville
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state: Tennessee
city: Corpus Christi
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Denton
country: United States
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state: Texas
city: Fort Worth
country: United States
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state: Texas
city: Houston
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state: Texas
city: Irving
country: United States
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state: Texas
city: Irving
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Waco
country: United States
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state: Texas
city: Pleasant Grove
country: United States
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state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Ballerup
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Bekescsaba
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Kecskemet
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Tatabanya
country: Hungary
facility: Pfizer Investigational Site
city: D.F
country: Mexico
facility: Pfizer Investigational Site
city: Dunedin
country: New Zealand
facility: Pfizer Investigational Site
state: NZ
city: Wellington
country: New Zealand
facility: Pfizer Investigational Site
state: NZ
city: Christchurch
country: New Zealand
facility: Pfizer Investigational Site
city: Alesund
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.