Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

NCT00238732

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

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaginal Atrophy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-65 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 65 years

- Intact uterus

- At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

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


- Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected
estrogen-dependent neoplasia


- Thrombophlebitis, thrombosis or thromboembolic disorders


- Neuro-ocular disease

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Vaginal AtrophyStudy Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
NCT00238732
  1. Birmingham, Alabama
  2. Montgomery, Alabama
  3. Scottsdale, Arizona
  4. Tucson, Arizona
  5. Oakland, California
  6. San Diego, California
  7. Upland, California
  8. Denver, Colorado
  9. Avon, Connecticut
  10. Groton, Connecticut
  11. Waterbury, Connecticut
  12. Aventura, Florida
  13. Gainesville, Florida
  14. Miami, Florida
  15. Palm Harbor, Florida
  16. Palm Springs, Florida
  17. Pinnellas Park, Florida
  18. Stuart, Florida
  19. Tampa, Florida
  20. West Palm Beach, Florida
  21. Atlanta, Georgia
  22. Conyers, Georgia
  23. Douglasville, Georgia
  24. Savannah, Georgia
  25. Idaho Falls, Idaho
  26. Champaign, Illinois
  27. Chicago, Illinois
  28. Kansas City, Kansas
  29. Shreveport, Louisiana
  30. Baltimore, Maryland
  31. Ann Arbor, Michigan
  32. Booklyn Center, Minnesota
  33. Chaska, Minnesota
  34. Jackson, Mississippi
  35. Kansas, Mississippi
  36. Creve Cour, Missouri
  37. St. Louis, Missouri
  38. Lebanon, New Hampshire
  39. Livingston, New Jersey
  40. New Brunswick, New Jersey
  41. Winston-Salem, North Carolina
  42. Fargo, North Dakota
  43. Jamestown, North Dakota
  44. Cincinnati, Ohio
  45. Columbus, Ohio
  46. Toledo, Ohio
  47. Oklahoma City, Oklahoma
  48. Medford, Oregon
  49. Erie, Pennsylvania
  50. Media, Pennsylvania
  51. West Reading, Pennsylvania
  52. Hilton Head Island, South Carolina
  53. Sioux Falls, South Dakota
  54. Nashville, Tennessee
  55. Dallas, Texas
  56. Denton, Texas
  57. Galveston, Texas
  58. San Antonio, Texas
  59. Salt Lake City, Utah
  60. Burlington, Vermont
  61. Norfolk, Virginia
  62. Richmond, Virginia
  63. Seattle, Washington
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
Official Title  ICMJE A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
Brief Summary The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Vaginal Atrophy
Intervention  ICMJE Drug: Bazedoxifene/Conjugated Estrogen
Study Arms  ICMJE Not Provided
Publications * Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.

*   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
Enrollment  ICMJE
 (submitted: October 12, 2005)
650
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, postmenopausal women, aged 40 to 65 years
  • Intact uterus
  • At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion Criteria:

  • Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
  • Thrombophlebitis, thrombosis or thromboembolic disorders
  • Neuro-ocular disease
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238732
Other Study ID Numbers  ICMJE 3115A1-306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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