Status:
TERMINATED
Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Eligibility:
FEMALE
40-75 years
Brief Summary
This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at...
Detailed Description
The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible ...
Eligibility Criteria
Inclusion
- Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
- Has completed 24 months of treatment.
- Was at least 80% compliant with study drug administration.
Exclusion
- Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
- Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00847821
Start Date
May 1 2009
End Date
August 1 2010
Last Update
September 6 2010
Active Locations (22)
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1
Pfizer Investigational Site
Fort Myers, Florida, United States, 33916
2
Pfizer Investigational Site
Gainesville, Florida, United States, 32606
3
Pfizer Investigational Site
New Port Richey, Florida, United States, 34652
4
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409