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

NCT00808132

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235, United States
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause, Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Menopause, OsteoporosisStudy Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
NCT00808132
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Chandler, Arizona
  4. Glendale, Arizona
  5. Mesa, Arizona
  6. Peoria, Arizona
  7. Phoenix, Arizona
  8. Scottsdale, Arizona
  9. Tucson, Arizona
  10. Tucson, Arizona
  11. Tucson, Arizona
  12. Little Rock, Arkansas
  13. Carmichael, California
  14. Sacramento, California
  15. San Diego, California
  16. San Diego, California
  17. San Diego, California
  18. Upland, California
  19. Vista, California
  20. Walnut Creek, California
  21. Colorado Springs, Colorado
  22. Colorado Springs, Colorado
  23. Denver, Colorado
  24. Denver, Colorado
  25. Lakewood, Colorado
  26. New London, Connecticut
  27. Boynton Beach, Florida
  28. Clearwater, Florida
  29. Crystal River, Florida
  30. Daytona Beach, Florida
  31. Deland, Florida
  32. Ft. Lauderdale, Florida
  33. Ft. Lauderdale, Florida
  34. Ft. Myers, Florida
  35. Lake Worth, Florida
  36. Miami Springs, Florida
  37. Miami, Florida
  38. Miami, Florida
  39. New Port Richey, Florida
  40. Pinellas Park, Florida
  41. Sunrise, Florida
  42. Tampa, Florida
  43. Vero Beach, Florida
  44. Atlanta, Georgia
  45. Augusta, Georgia
  46. Decatur, Georgia
  47. Decatur, Georgia
  48. Savannah, Georgia
  49. Savannah, Georgia
  50. Boise, Idaho
  51. Idaho Falls, Idaho
  52. Meridian, Idaho
  53. Chicago, Illinois
  54. Rockford, Illinois
  55. South Bend, Indiana
  56. Overland Park, Kansas
  57. Lexington, Kentucky
  58. Lousiville, Kentucky
  59. Bangor, Maine
  60. Ann Arbor, Michigan
  61. Kalamazoo, Michigan
  62. Paw Paw, Michigan
  63. Saginaw, Michigan
  64. Southfield, Michigan
  65. Brooklyn Center, Minnesota
  66. Chaska, Minnesota
  67. Robbinsdale, Minnesota
  68. St Louis, Missouri
  69. Billings, Montana
  70. Billings, Montana
  71. Lincoln, Nebraska
  72. Omaha, Nebraska
  73. Las Vegas, Nevada
  74. Las Vegas, Nevada
  75. North Las Vegas, Nevada
  76. Reno, Nevada
  77. Lebanon, New Hampshire
  78. Brick, New Jersey
  79. New Brunswick, New Jersey
  80. Albuquerque, New Mexico
  81. Albuquerque, New Mexico
  82. New York, New York
  83. Port Jefferson, New York
  84. Charlotte, North Carolina
  85. Kernersville, North Carolina
  86. Winston-Salem, North Carolina
  87. Bismarck, North Dakota
  88. Fargo, North Dakota
  89. Minot, North Dakota
  90. Akron, Ohio
  91. Cincinnati, Ohio
  92. Cleveland, Ohio
  93. Cleveland, Ohio
  94. Columbus, Ohio
  95. Dayton, Ohio
  96. Englewood, Ohio
  97. Mayfield Heights, Ohio
  98. Eugene, Oregon
  99. Medford, Oregon
  100. Portland, Oregon
  101. Erie, Pennsylvania
  102. Hopwood, Pennsylvania
  103. Jenkintown, Pennsylvania
  104. Johnstown, Pennsylvania
  105. Philadelphia, Pennsylvania
  106. Philadelphia, Pennsylvania
  107. Pittsburgh, Pennsylvania
  108. West Reading, Pennsylvania
  109. Wexford, Pennsylvania
  110. Warwick, Rhode Island
  111. Bluffton, South Carolina
  112. Greer, South Carolina
  113. Hilton Head Island, South Carolina
  114. Sioux Falls, South Dakota
  115. Sioux Falls, South Dakota
  116. Sioux Falls, South Dakota
  117. Watertown, South Dakota
  118. Chattanooga, Tennessee
  119. Jackson, Tennessee
  120. Knoxville, Tennessee
  121. Memphis, Tennessee
  122. Nashville, Tennessee
  123. Corpus Christi, Texas
  124. Dallas, Texas
  125. Denton, Texas
  126. Fort Worth, Texas
  127. Houston, Texas
  128. Irving, Texas
  129. Irving, Texas
  130. Plano, Texas
  131. San Antonio, Texas
  132. San Antonio, Texas
  133. San Antonio, Texas
  134. Waco, Texas
  135. Pleasant Grove, Utah
  136. Salt Lake City, Utah
  137. Sandy, Utah
  138. Charlottesville, Virginia
  139. Norfolk, Virginia
  140. Norfolk, Virginia
  141. Richmond, Virginia
  142. Seattle, Washington
  143. Tacoma, Washington
  144. Caba, Buenos Aires
  145. Caba, Buenos Aires
  146. Buenos Aires,
  147. Buenos Aires,
  148. Randwick, New South Wales
  149. St Leonards, New South Wales
  150. Perth, Western Australia
  151. Santiago, RM
  152. Medellin, Antioquia
  153. Barranquilla, Atlantico
  154. Bogota, Cundinamarca
  155. Aalborg,
  156. Ballerup,
  157. Vejle,
  158. Kuopio,
  159. Oulu,
  160. Bekescsaba,
  161. Budapest,
  162. Budapest,
  163. Debrecen,
  164. Debrecen,
  165. Kecskemet,
  166. Nyiregyhaza,
  167. Tatabanya,
  168. D.F,
  169. Dunedin, NZ
  170. Wellington, NZ
  171. Christchurch,
  172. Alesund,
  173. Hamar,
  174. Lublin,
  175. Poznan,
  176. Warszawa,
  177. Warszawa,
  178. Wroclaw,
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Osteoporosis
Intervention  ICMJE
  • Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
    One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
  • Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
    One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
  • Drug: bazedoxifene 20 mg
    One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
  • Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
    One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
    Other Name: Prempro
  • Drug: Placebo
    One capsule, placebo (over-encapsulated), once a day for one year.
Study Arms  ICMJE
  • Experimental: 1
    bazedoxifene 20 mg/conjugated estrogens 0.45 mg
    Intervention: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
  • Experimental: 2
    bazedoxifene 20 mg/conjugated estrogens 0.625 mg
    Intervention: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
  • Experimental: 3
    bazedoxifene 20 mg
    Intervention: Drug: bazedoxifene 20 mg
  • Active Comparator: 4
    Prempro
    Intervention: Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2014)
1886
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
1720
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   Colombia,   Denmark,   Finland,   Hungary,   Mexico,   New Zealand,   Norway,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808132
Other Study ID Numbers  ICMJE 3115A1-3307
B2311009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP