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

Condition(s) targeted: Menopause; Osteoporosis

Intervention: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg (Drug); bazedoxifene 20 mg/ conjugated estrogens 0.625 mg (Drug); bazedoxifene 20 mg (Drug); conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Incidence of Endometrial Hyperplasia and Changes in Bone Mineral Density

Secondary outcome: Breast Density, Incidence of Uterine Bleeding, Incidence of Breast Tenderness

Minimum age: 40 Years. Maximum age: 64 Years. Gender(s): Female.

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.

Trial Manager, Email: clintrialparticipation@wyeth.com

Aalborg DK-9000, Denmark; Recruiting

Ballerup DK-2750, Denmark; Recruiting

Vejle DK-7100, Denmark; Recruiting

Oulu FI-90100, Finland; Recruiting

Kuopio FI-7-211, Finland; Recruiting

Debrecen 04012, Hungary; Recruiting

Debrecan 04043, Hungary; Recruiting

Nyiregyhaza 04400, Hungary; Recruiting

Bekescsaba 05600, Hungary; Recruiting

Tatabanya 02800, Hungary; Enrolling by invitation

Christchurch 0000, New Zealand; Recruiting

Wellington 0000, New Zealand; Recruiting

Dunedin, New Zealand; Recruiting

Warsaw 02-341, Poland; Recruiting

Lublin 20-090, Poland; Recruiting

Warsaw 01-809, Poland; Recruiting

Wroclaw 50-088, Poland; Recruiting

Poznan 60-535, Poland; Recruiting

Birmingham, Alabama 35235, United States; Recruiting

Mobile, Alabama 36608, United States; Recruiting

Scottsdale, Arizona 85251, United States; Recruiting

Tucson, Arizona 85710, United States; Recruiting

Mesa, Arizona 85206, United States; Recruiting

Chandler, Arizona 85225, United States; Recruiting

Glendale, Arizona 85308, United States; Recruiting

Peoria, Arizona 85381, United States; Recruiting

Tucson, Arizona 85715, United States; Recruiting

Phoenix, Arizona 85032, United States; Recruiting

Little Rock, Arkansas 72223, United States; Recruiting

San Diego, California 92108, United States; Recruiting

Walnut Creek, California 94598, United States; Recruiting

San Diego, California 92123, United States; Recruiting

Sacramento, California 95821, United States; Recruiting

Vista, California 92083, United States; Recruiting

Carmichael, California 95609, United States; Recruiting

San Diego, California 92103, United States; Recruiting

Denver, Colorado 80218, United States; Recruiting

Denver, Colorado 80220, United States; Recruiting

Colorado Springs, Colorado 80907, United States; Recruiting

Colorado Springs, Colorado 80910, United States; Recruiting

Lakewood, Colorado 80228, United States; Recruiting

New London, Connecticut 06320, United States; Recruiting

Clearwater, Florida 33759, United States; Recruiting

Boynton Beach, Florida 33472, United States; Recruiting

Miami, Florida 33169, United States; Recruiting

Lake Worth, Florida 33461, United States; Recruiting

Ft. Lauderdale, Florida 33316, United States; Recruiting

Crystal River, Florida 34429, United States; Withdrawn

New Port Richey, Florida 34652, United States; Recruiting

Sunrise, Florida 33323, United States; Recruiting

Miami, Florida 33143, United States; Recruiting

Jacksonville, Florida 32207, United States; Withdrawn

Ft. Lauderdale, Florida 33328, United States; Recruiting

Tampa, Florida 33606, United States; Recruiting

Crystal River, Florida 34427, United States; Recruiting

Ft. Myers, Florida 33916, United States; Recruiting

Miami, Florida 33186, United States; Withdrawn

Pinellas Park, Florida 33781, United States; Recruiting

Daytona Beach, Florida 32114, United States; Recruiting

New Port Richey, Florida 34651, United States; Recruiting

DeLand, Florida 32720, United States; Recruiting

Atlanta, Georgia 30308, United States; Withdrawn

Atlanta, Georgia 30342, United States; Recruiting

Decatur, Georgia 30033, United States; Recruiting

Savannah, Georgia 31406, United States; Recruiting

Idaho Falls, Idaho 83404, United States; Recruiting

Boise, Idaho 83701, United States; Recruiting

Boise, Idaho 83642, United States; Recruiting

Chicago, Illinois 60610, United States; Recruiting

Addison, Illinois 60101, United States; Withdrawn

Rockford, Illinois 61107, United States; Recruiting

South Bend, Indiana 46601, United States; Recruiting

Indianapolis, Indiana 46260, United States; Withdrawn

Overland Park, Kansas 66210, United States; Recruiting

Louisville, Kentucky 40291, United States; Recruiting

Lexington, Kentucky 40536, United States; Recruiting

Bangor, Maine 04401, United States; Recruiting

Ann Arbor, Michigan 48106, United States; Recruiting

Paw Paw, Michigan 49079, United States; Recruiting

Saginaw, Michigan 48604, United States; Recruiting

Brooklyn Center, Minnesota 55430, United States; Recruiting

Chaska, Minnesota 55318, United States; Recruiting

Creve Coeur, Missouri 63141, United States; Recruiting

Billings, Montana 59102, United States; Recruiting

Billings, Montana 59101, United States; Recruiting

Lincoln, Nebraska 68510, United States; Recruiting

Omaha, Nebraska 68131, United States; Recruiting

North Las Vegas, Nevada 89030, United States; Recruiting

Las Vegas, Nevada 89146, United States; Recruiting

Reno, Nevada 89502, United States; Recruiting

Lebanon, New Hampshire 03756, United States; Recruiting

New Brunswick, New Jersey 08901, United States; Recruiting

Brick, New Jersey 08723, United States; Recruiting

Albuquerque, New Mexico 87106, United States; Recruiting

Albuquerque, New Mexico 87102, United States; Recruiting

St. Leonards, New South Wales 0000, Australia; Recruiting

Randwick, New South Wales 0000, Australia; Recruiting

Port Jefferson, New York 11777, United States; Recruiting

New York, New York 10032, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Kernersville, North Carolina 27284, United States; Recruiting

Jamestown, North Dakota 58401, United States; Withdrawn

Bismarck, North Dakota 58501, United States; Recruiting

Fargo, North Dakota 59103, United States; Recruiting

Minot, North Dakota 58701, United States; Recruiting

Cincinnati, Ohio 45249, United States; Recruiting

Columbus, Ohio 43213, United States; Recruiting

Dayton, Ohio 45439, United States; Recruiting

Cleveland, Ohio 44122, United States; Recruiting

Mayfield Heights, Ohio 44124, United States; Recruiting

Oklahoma City, Oklahoma 73112, United States; Withdrawn

Norman, Oklahoma 73069, United States; Withdrawn

Eugene, Oregon 97401, United States; Recruiting

Portland, Oregon 97239, United States; Withdrawn

Medford, Oregon 97504, United States; Recruiting

Portland, Oregon 97211, United States; Recruiting

Philadelphia, Pennsylvania 19114, United States; Recruiting

Pittsburgh, Pennsylvania 15206, United States; Recruiting

Wexford, Pennsylvania 15090, United States; Recruiting

Jenkintown, Pennsylvania 19046, United States; Recruiting

Hopwood, Pennsylvania 15445, United States; Recruiting

West Reding, Pennsylvania 19611, United States; Recruiting

Johnstown, Pennsylvania 15905, United States; Recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

Erie, Pennsylvania 16502, United States; Recruiting

Warwick, Rhode Island 02886, United States; Recruiting

Hilton Head Island, South Carolina 29926, United States; Withdrawn

Hilton Head Island, South Carolina 29926, United States; Recruiting

Greer, South Carolina 29651, United States; Recruiting

Sioux Falls, South Dakota 57104, United States; Recruiting

Watertown, South Dakota 57201, United States; Recruiting

Sioux Falls, South Dakota 57105, United States; Recruiting

Chattanooga, Tennessee 37404, United States; Recruiting

Jackson, Tennessee 38305, United States; Recruiting

Memphis, Tennessee 38120, United States; Recruiting

Nashville, Tennessee 37203, United States; Recruiting

Knoxville, Tennessee 37920, United States; Recruiting

Nashville, Tennessee 37203, United States; Not yet recruiting

Denton, Texas 76210, United States; Recruiting

Waco, Texas 76712, United States; Recruiting

Houston, Texas 77030, United States; Withdrawn

Midland, Texas 79705, United States; Withdrawn

Irving, Texas 76052, United States; Recruiting

Houston, Texas 77030, United States; Recruiting

San Antonio, Texas 78217, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Pleasant Grove, Utah 84062, United States; Recruiting

Sandy, Utah 84070, United States; Recruiting

Salt Lake City, Utah 84117, United States; Recruiting

Burlington, Vermont 05401, United States; Withdrawn

Richmond, Virginia 23294, United States; Recruiting

Norfolk, Virginia 23507, United States; Recruiting

Norfolk, Virginia 23502, United States; Recruiting

Spokane, Washington 99204, United States; Withdrawn

Tacoma, Washington 98405, United States; Recruiting

Seattle, Washington 98105, United States; Recruiting

Nedlands, Western Australia 0000, Australia; Recruiting

Menomonee Fall, Wisconsin 53051, United States; Withdrawn

Starting date: January 2009
Ending date: July 2011
Last updated: September 21, 2009