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RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene


Phase 3
40 Years
75 Years
Not Enrolling
Female
Postmenopause

Thank you

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