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

NCT00808132 | Completed Phase 3 Results

• 2 other identifiers: 3115A1-3307B2311009
• Study Type: interventional
• Target: 1,886
• Locations: 12 countries
• Sites: 178

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.

Conditions

Menopause; Osteoporosis

Keywords

Postmenopausal Women; Bazedoxifene/Conjugated Estrogens

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Month 12

Secondary Outcomes (10)

• Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study

  Baseline, Month 6

• Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study

  Baseline, Month 6, Month 12

• Percentage of Participants With Cumulative Amenorrhea: Main Study

  Day 1 up to Day 364

• Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study

  Baseline, Month 12

• Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study

  Baseline, Month 6, 12

Other Outcomes (1)

• Percentage of Participants With Breast Tenderness

  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

Study Arms (5)

1

EXPERIMENTAL

bazedoxifene 20 mg/conjugated estrogens 0.45 mg

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

2

EXPERIMENTAL

bazedoxifene 20 mg/conjugated estrogens 0.625 mg

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

3

EXPERIMENTAL

bazedoxifene 20 mg

Drug: bazedoxifene 20 mg

4

ACTIVE COMPARATOR

Prempro

Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg DRUG

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

1

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg DRUG

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

2

bazedoxifene 20 mg DRUG

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

3

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg DRUG

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

Also known as: Prempro

4

Placebo DRUG

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

5

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (178)

Pfizer Investigational Site

Birmingham, Alabama, 35235, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85225, United States

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Glendale, Arizona, 85308, United States

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Mesa, Arizona, 85206, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85715, United States

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Little Rock, Arkansas, 72223, United States

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Carmichael, California, 95608, United States

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Sacramento, California, 95821, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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Upland, California, 91786, United States

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Vista, California, 92083, United States

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Walnut Creek, California, 94598, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80910, United States

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Denver, Colorado, 80218, United States

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Denver, Colorado, 80220, United States

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Lakewood, Colorado, 80228, United States

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New London, Connecticut, 06320, United States

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Boynton Beach, Florida, 33472, United States

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Clearwater, Florida, 33759, United States

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Crystal River, Florida, 34429, United States

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Daytona Beach, Florida, 32114, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33316, United States

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Fort Lauderdale, Florida, 33328, United States

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Fort Myers, Florida, 33916, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33169, United States

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Miami Springs, Florida, 33166, United States

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New Port Richey, Florida, 34652, United States

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Pinellas Park, Florida, 33781, United States

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Sunrise, Florida, 33323, United States

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Tampa, Florida, 33606, United States

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Vero Beach, Florida, 32960, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30909, United States

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Decatur, Georgia, 30033, United States

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Decatur, Georgia, 30319, United States

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Savannah, Georgia, 31405, United States

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Savannah, Georgia, 31406, United States

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Boise, Idaho, 83702, United States

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Idaho Falls, Idaho, 83404, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60610, United States

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Rockford, Illinois, 61107, United States

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South Bend, Indiana, 46601, United States

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Overland Park, Kansas, 66210, United States

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Lexington, Kentucky, 40536-0293, United States

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Lousiville, Kentucky, 40291, United States

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Bangor, Maine, 4401, United States

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Ann Arbor, Michigan, 48106, United States

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Kalamazoo, Michigan, 49009, United States

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Paw Paw, Michigan, 49079, United States

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Saginaw, Michigan, 48604, United States

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Southfield, Michigan, 48034, United States

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Brooklyn Center, Minnesota, 55430, United States

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Chaska, Minnesota, 55318, United States

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Robbinsdale, Minnesota, 55422, United States

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St Louis, Missouri, 63131, United States

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Billings, Montana, 59101, United States

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Billings, Montana, 59102, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89146, United States

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North Las Vegas, Nevada, 89030, United States

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Reno, Nevada, 89502, United States

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Lebanon, New Hampshire, 03756, United States

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Brick, New Jersey, 08723, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87102, United States

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Albuquerque, New Mexico, 87106, United States

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New York, New York, 10032, United States

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Port Jefferson, New York, 11777, United States

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Charlotte, North Carolina, 29209, United States

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Kernersville, North Carolina, 27284, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58103, United States

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Minot, North Dakota, 58701, United States

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Akron, Ohio, 44311, United States

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Cincinnati, Ohio, 45236, United States

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Cleveland, Ohio, 44106-6010, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45439, United States

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Englewood, Ohio, 45322, United States

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Mayfield Heights, Ohio, 44124, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97205, United States

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Erie, Pennsylvania, 16502, United States

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Hopwood, Pennsylvania, 15445, United States

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Jenkintown, Pennsylvania, 19046, United States

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Johnstown, Pennsylvania, 15905, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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West Reading, Pennsylvania, 19611, United States

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Wexford, Pennsylvania, 15090, United States

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Warwick, Rhode Island, 02886, United States

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Bluffton, South Carolina, 29910, United States

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Greer, South Carolina, 29651, United States

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Hilton Head Island, South Carolina, 29926, United States

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Sioux Falls, South Dakota, 57104, United States

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Sioux Falls, South Dakota, 57105, United States

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Sioux Falls, South Dakota, 67105, United States

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Watertown, South Dakota, 57201, United States

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Chattanooga, Tennessee, 37404, United States

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Jackson, Tennessee, 38305, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75390, United States

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Denton, Texas, 76210, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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Irving, Texas, 75061, United States

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Irving, Texas, 75062, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78154, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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Waco, Texas, 76712, United States

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Pleasant Grove, Utah, 84062, United States

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Salt Lake City, Utah, 84117, United States

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Sandy City, Utah, 84070, United States

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Charlottesville, Virginia, 22903, United States

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Norfolk, Virginia, 23502, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, 98105, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, Buenos Aires, C1117ABH, Argentina

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Caba, Buenos Aires, C1012AAR, Argentina

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Caba, Buenos Aires, C1425AGC, Argentina

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Buenos Aires, C1128AAF, Argentina

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Randwick, New South Wales, 2031, Australia

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St Leonards, New South Wales, 2065, Australia

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Perth, Western Australia, 6009, Australia

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Santiago, RM, 8320152, 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, 9000, Denmark

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Ballerup Municipality, 2750, Denmark

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Vejle, 7100, Denmark

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Kuopio, 70110, Finland

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Oulu, 90 100, Finland

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Békéscsaba, H-5600, Hungary

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Budapest, 1106, Hungary

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Budapest, H-1125, Hungary

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Debrecen, H-4012, Hungary

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Debrecen, H-4043, Hungary

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Kecskemét, 6000, Hungary

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Nyíregyháza, H-4400, Hungary

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Tatabánya, H-2800, 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, 8014, New Zealand

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Ålesund, Norway, NO-6003, Norway

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Hamar, NO-2317, Norway

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Poznan, Poland, 60-535, Poland

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Wroclaw, Poland, 50-088, Poland

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Lublin, 20-090, Poland

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Warsaw, 01-809, Poland

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Warsaw, 02-341, Poland

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Related Publications (2)

• 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.

  PMID: 24438370 DERIVED

• 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.

  PMID: 23635731 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoporosis

Interventions

bazedoxifene; Estrogens, Conjugated (USP); Medroxyprogesterone Acetate; Prempro

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 8, 2014
• Results First Posted: December 20, 2013

Record last verified: 2014-03

Locations

ME (1); NO (2); DK (3); FI (2); CL (1); AR (4); CO (3); US (143); HU (8); NZ (3); AU (3); PL (5)