Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens

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NCT00550303

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy, post menopausal women ages 45 to 70

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


- Male subjects

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
Official Title  ICMJE An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women
Brief Summary The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: bazedoxifene/conjugated estrogens combination
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: October 25, 2007)		28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, post menopausal women ages 45 to 70

Exclusion Criteria:

  • Male subjects
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00550303
Other Study ID Numbers  ICMJE 3115A1-1123
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