Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene

Stopped early · Has a placebo group

Conditions studied: Postmenopause

In brief

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 an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.

Key facts

Study ID

NCT00847821

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

185

Starts

2009-05-01

Expected to finish

2010-08-01

Last updated by the study team

2010-09-06

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Pfizer Investigational Site — Fort Myers, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — New Port Richey, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Southfield, Michigan, United States
• Pfizer Investigational Site — Chaska, Minnesota, United States
• Pfizer Investigational Site — Billings, Montana, United States
• Pfizer Investigational Site — New Brunswick, New Jersey, United States
• Pfizer Investigational Site — Las Vegas, New Mexico, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Raleigh, North Carolina, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Wexford, Pennsylvania, United States
• Pfizer Investigational Site — Greenville, South Carolina, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Charlottesville, Virginia, United States
• Pfizer Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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