- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479778
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women
The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens.
It is an open label study with no placebo control or comparator drugs.
Subjects will take one dose of the investigation formulation daily for 14 days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32608
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
- Postmenopausal women, aged 40 to 65 years.
- Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
- A history or active presence of clinically relevant important medical disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetic analyses.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Study Completion (ACTUAL)
July 1, 2007
Study Registration Dates
First Submitted
May 25, 2007
First Submitted That Met QC Criteria
May 25, 2007
First Posted (ESTIMATE)
May 28, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3115A1-1121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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