MenopausePhase 3NCT00808132

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

A Phase 3 study testing bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg and bazedoxifene 20 mg in people with Menopause and Osteoporosis, run by Pfizer at 178 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 40 to 64 years, women only
Conditions the study is for: Menopause, Osteoporosis
What is being tested?: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg and bazedoxifene 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,886 participants
Where: 178 sitesin 12 countries
Study dates: Jan 2009to Feb 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 64 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

178 sites in 12 countries.

Country

City, postcode or hospital

178 sites in 12 countries

United States143 sites

Pfizer Investigational Site
Akron, Ohio, 44311
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Bangor, Maine, 4401
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Billings, Montana, 59102
Pfizer Investigational Site
Birmingham, Alabama, 35235
Pfizer Investigational Site
Bismarck, North Dakota, 58501
Pfizer Investigational Site
Bluffton, South Carolina, 29910
Pfizer Investigational Site
Boise, Idaho, 83702
Pfizer Investigational Site
Boynton Beach, Florida, 33472
Pfizer Investigational Site
Brick, New Jersey, 08723
Pfizer Investigational Site
Brooklyn Center, Minnesota, 55430
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
Charlotte, North Carolina, 29209
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Clearwater, Florida, 33759
Pfizer Investigational Site
Cleveland, Ohio, 44106-6010
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Colorado Springs, Colorado, 80907
Pfizer Investigational Site
Colorado Springs, Colorado, 80910
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Corpus Christi, Texas, 78414
Pfizer Investigational Site
Crystal River, Florida, 34429
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Dayton, Ohio, 45439
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Decatur, Georgia, 30319
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Denton, Texas, 76210
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Englewood, Ohio, 45322
Pfizer Investigational Site
Erie, Pennsylvania, 16502
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fort Lauderdale, Florida, 33316
Pfizer Investigational Site
Fort Lauderdale, Florida, 33328
Pfizer Investigational Site
Fort Myers, Florida, 33916
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Glendale, Arizona, 85308
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hilton Head Island, South Carolina, 29926
Pfizer Investigational Site
Hopwood, Pennsylvania, 15445
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Irving, Texas, 75062
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046
Pfizer Investigational Site
Johnstown, Pennsylvania, 15905
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Kernersville, North Carolina, 27284
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Lakewood, Colorado, 80228
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Lexington, Kentucky, 40536-0293
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Little Rock, Arkansas, 72223
Pfizer Investigational Site
Lousiville, Kentucky, 40291
Pfizer Investigational Site
Mayfield Heights, Ohio, 44124
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Meridian, Idaho, 83642
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Miami Springs, Florida, 33166
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New London, Connecticut, 06320
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
North Las Vegas, Nevada, 89030
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Paw Paw, Michigan, 49079
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Pinellas Park, Florida, 33781
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Pleasant Grove, Utah, 84062
Pfizer Investigational Site
Port Jefferson, New York, 11777
Pfizer Investigational Site
Portland, Oregon, 97205
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Robbinsdale, Minnesota, 55422
Pfizer Investigational Site
Rockford, Illinois, 61107
Pfizer Investigational Site
Sacramento, California, 95821
Pfizer Investigational Site
Saginaw, Michigan, 48604
Pfizer Investigational Site
Salt Lake City, Utah, 84117
Pfizer Investigational Site
San Antonio, Texas, 78154
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
Savannah, Georgia, 31405
Pfizer Investigational Site
Savannah, Georgia, 31406
Pfizer Investigational Site
Scottsdale, Arizona, 85251
Pfizer Investigational Site
Seattle, Washington, 98105
Pfizer Investigational Site
Sioux Falls, South Dakota, 57104
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
Sioux Falls, South Dakota, 67105
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
St Louis, Missouri, 63131
Pfizer Investigational Site
Sunrise, Florida, 33323
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tucson, Arizona, 85710
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
Vista, California, 92083
Pfizer Investigational Site
Waco, Texas, 76712
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Watertown, South Dakota, 57201
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Pfizer Investigational Site
Wexford, Pennsylvania, 15090
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

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Hungary8 sites

Pfizer Investigational Site
Békéscsaba, H-5600
Pfizer Investigational Site
Budapest, 1106
Pfizer Investigational Site
Budapest, H-1125
Pfizer Investigational Site
Debrecen, H-4012
Pfizer Investigational Site
Debrecen, H-4043
Pfizer Investigational Site
Kecskemét, 6000
Pfizer Investigational Site
Nyíregyháza, H-4400
Pfizer Investigational Site
Tatabánya, H-2800

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Poland5 sites

Pfizer Investigational Site
Lublin, 20-090
Pfizer Investigational Site
Poznan, Poland, 60-535
Pfizer Investigational Site
Warsaw, 01-809
Pfizer Investigational Site
Warsaw, 02-341
Pfizer Investigational Site
Wroclaw, Poland, 50-088

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Argentina4 sites

Pfizer Investigational Site
Buenos Aires, Buenos Aires, C1117ABH
Pfizer Investigational Site
Buenos Aires, C1128AAF
Pfizer Investigational Site
Caba, Buenos Aires, C1012AAR
Pfizer Investigational Site
Caba, Buenos Aires, C1425AGC

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Australia3 sites

Pfizer Investigational Site
Perth, Western Australia, 6009
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
St Leonards, New South Wales, 2065

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Colombia3 sites

Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Medellín, Antioquia

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Denmark3 sites

Pfizer Investigational Site
Aalborg, 9000
Pfizer Investigational Site
Ballerup Municipality, 2750
Pfizer Investigational Site
Vejle, 7100

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New Zealand3 sites

Pfizer Investigational Site
Christchurch, 8014
Pfizer Investigational Site
Dunedin, NZ
Pfizer Investigational Site
Wellington, NZ

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Finland2 sites

Pfizer Investigational Site
Kuopio, 70110
Pfizer Investigational Site
Oulu, 90 100

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Norway2 sites

Pfizer Investigational Site
Ålesund, Norway, NO-6003
Pfizer Investigational Site
Hamar, NO-2317

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Chile1 site

Pfizer Investigational Site
Santiago, RM, 8320152

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Mexico1 site

Pfizer Investigational Site
D.F, Mexico

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About this study

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

Conditions: Menopause, Osteoporosis
Being tested: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg, bazedoxifene 20 mg, conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg, Placebo
Keywords: Postmenopausal Women, Bazedoxifene/Conjugated Estrogens
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bazedoxifene 20 mg/ conjugated estrogens 0.45 mgDrug
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
bazedoxifene 20 mg/ conjugated estrogens 0.625 mgDrug
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
bazedoxifene 20 mgDrug
One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mgDrug
Also called Prempro
One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
PlaceboDrug
One capsule, placebo (over-encapsulated), once a day for one year.

Study groups in NCT00808132
Study group	Role	What they receive
1	Experimental	bazedoxifene 20 mg/conjugated estrogens 0.45 mg Receives: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
2	Experimental	bazedoxifene 20 mg/conjugated estrogens 0.625 mg Receives: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
3	Experimental	bazedoxifene 20 mg Receives: Drug: bazedoxifene 20 mg
4	Active comparator	Prempro Receives: Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
5	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
Measured: Month 12
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Measured: Baseline, Month 12

Secondary outcomes (10)

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Measured: Baseline, Month 6
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Measured: Baseline, Month 6, Month 12
Percentage of Participants With Cumulative Amenorrhea: Main Study
Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.
Measured: Day 1 up to Day 364
Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study
Measured: Baseline, Month 12
Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.
Measured: Baseline, Month 6, 12
Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Measured: Baseline
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Measured: Baseline, Month 3
Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Measured: Baseline
Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Measured: Baseline, Month 3
Percentage of Participants With Uterine Bleeding
Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Feb 2011

First posted15 Dec 2008 (estimated)
Study startJan 2009
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,886 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808132
Sponsor's protocol ID: 3115A1-3307
Other IDs: B2311009
Status last verified: Mar 2014
First submitted: 12 Dec 2008
Last updated: 8 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24438370
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.
PubMed 23635731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00808132
Acronym / sponsor ID: 3115A1-3307
Conditions: Menopause, Osteoporosis
Keywords: Postmenopausal Women, Bazedoxifene/Conjugated Estrogens
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,886 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
1	Experimental	Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mgbazedoxifene 20 mg/conjugated estrogens 0.45 mg
2	Experimental	Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mgbazedoxifene 20 mg/conjugated estrogens 0.625 mg
3	Experimental	Drug: bazedoxifene 20 mgbazedoxifene 20 mg
4	Active comparator	Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mgPrempro
5	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 to 64 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bazedoxifene 20 mg/ conjugated estrogens 0.45 mgOne capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.	Drug	1
bazedoxifene 20 mg/ conjugated estrogens 0.625 mgOne capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.	Drug	2
bazedoxifene 20 mgOne capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.	Drug	3
conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mgAlso: PremproOne capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.	Drug	4
PlaceboOne capsule, placebo (over-encapsulated), once a day for one year.	Drug	5

Primary outcome

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
Time frame: Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
Time frame: Baseline, Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.

10 secondary outcomes

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
Time frame: Baseline, Month 6
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
Time frame: Baseline, Month 6, Month 12
Percentage of Participants With Cumulative Amenorrhea: Main Study
Time frame: Day 1 up to Day 364
Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
Time frame: Baseline, Month 12
Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
Time frame: Baseline, Month 6, 12
Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
Time frame: Baseline
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
Time frame: Baseline, Month 3
Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
Time frame: Baseline
Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
Time frame: Baseline, Month 3
Percentage of Participants With Uterine Bleeding
Time frame: 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

Results and safety

Results posted to the registry on 20 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg	455	357
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg	481	393
Bazedoxifene 20 mg	239	185
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg	228	159
Placebo	483	383

Primary outcome: Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study

Time frame: Month 12. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg n = 335	Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg n = 368	Bazedoxifene 20 mg n = 169	Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg n = 149	Placebo n = 354
Definition 1	0.30 (NA to 1.41)	0.54 (NA to 1.70)	0.00 (NA to 1.76)	0.00 (NA to 1.99)	0.85 (NA to 2.18)
Definition 2	0.30 (NA to 1.41)	0.27 (NA to 1.28)	0.00 (NA to 1.76)	0.00 (NA to 1.99)	0.28 (NA to 1.33)

Population analysed: Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.

Primary outcome: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study

Time frame: Baseline, Month 12. Least squares mean (Standard Error). Unit: Percent Change

Measure	Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg n = 119	Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg n = 139	Bazedoxifene 20 mg n = 56	Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg n = 59	Placebo n = 139
Value	0.24 (0.29)	0.60 (0.27)	0.07 (0.40)	1.30 (0.39)	-1.28 (0.28)

Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg vs Placebo: Least Squares (LS) Mean Difference: 1.51 (95% CI 0.822 to 2.201), p <0.001, ANCOVA
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg vs Placebo: LS Mean Difference: 1.87 (95% CI 1.209 to 2.533), p <0.001, ANCOVA

Population analysed: Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg	16 of 445 (3.6%)	407 of 445 (91.5%)	Not reported
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg	17 of 474 (3.6%)	426 of 474 (89.9%)	Not reported
Bazedoxifene 20 mg	5 of 230 (2.2%)	207 of 230 (90%)	Not reported
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg	13 of 220 (5.9%)	197 of 220 (89.5%)	Not reported
Placebo	18 of 474 (3.8%)	423 of 474 (89.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24438370Pinkerton 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.
Derived from this study: PubMed 23635731Pinkerton 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

178 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Hungary, Poland, Argentina, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00808132, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.