Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

NCT00675688

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometrial Hyperplasia, Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 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 - 75 years inclusive

- Intact uterus

- Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

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


- A history or active presence of thrombophlebitis, thrombosis or thromboembolic
disorders


- A history or active presence of cerebrovascular accident, stroke, or transient
ischemic attack


- A history or active presence of malignancy, or treatment for malignancy, within the
previous 10 years


Additional criteria applies.

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Endometrial Hyperplasia, OsteoporosisStudy Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women NCT00675688
Female
40 Years+
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MULTIPLE SITES
Endometrial Hyperplasia, OsteoporosisStudy Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women NCT00242710
  1. Upland, California
  2. Inverness, Florida
  3. West Palm Beach, Florida
  4. Decatur, Georgia
  5. Honolulu, Hawaii
  6. Lexington, Kentucky
  7. Billings, Montana
  8. Eugene, Oregon
  9. Pittsburgh, Pennsylvania
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Official Title  ICMJE A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Brief Summary The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Hyperplasia
  • Osteoporosis
Intervention  ICMJE
  • Drug: Bazedoxifene/Conjugate Estrogens (CE)
  • Drug: Raloxifene
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Bazedoxifene/Conjugate Estrogens (CE)
  • Active Comparator: B
    Intervention: Drug: Raloxifene
  • Placebo Comparator: C
    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: May 9, 2008)
3544
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, postmenopausal women aged 40 - 75 years inclusive
  • Intact uterus
  • Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion Criteria:

  • A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
  • A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
  • A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 75 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00675688
Other Study ID Numbers  ICMJE 3115A1-303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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 May 2008

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