RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
40 Years
75 Years
Female
Postmenopause
Trial Information
RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
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 in case of a regulatory inspection of the 303 protocol.
Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP)
approval, and enrollment could not be met without the inclusion of these subjects. The
study was not terminated due to safety concerns.
Inclusion Criteria:
- 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 Criteria:
- 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)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
Outcome Time Frame:
Baseline, 6 months and 24 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Institutional Review Board
Study ID:
3115A1-1125
NCT ID:
NCT00847821
Start Date:
May 2009
Completion Date:
August 2010
Related Keywords:
- Postmenopause
- Adenoma
Name | Location |
|---|---|
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Livingston, New Jersey 07039 |
| Pfizer Investigational Site | Billings, Montana 59101 |
