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

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP); Raloxifene Hydrochloride

Criteria

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)