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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: Bazedoxifene 10 mg/CE 0.625 mg
* Drug: Bazedoxifene 20 mg/CE 0.625 mg
* Drug: Bazedoxifene 40 mg/CE 0.625 mg
* Drug: Bazedoxifene 10 mg/CE 0.45 mg
* Drug: Bazedoxifene 20 mg/CE 0.45 mg
* Drug: Bazedoxifene 40 mg/CE 0.45 mg
* Drug: Raloxifene 60 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bazedoxifene 10 mg/CE 0.625 mg<br> | Drug: Bazedoxifene 10 mg/CE 0.625 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Bazedoxifene 20 mg/CE 0.625 mg<br> | Drug: Bazedoxifene 20 mg/CE 0.625 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Bazedoxifene 40 mg/CE 0.625 mg<br> | Drug: Bazedoxifene 40 mg/CE 0.625 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Bazedoxifene 10 mg/CE 0.45 mg<br> | Drug: Bazedoxifene 10 mg/CE 0.45 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Bazedoxifene 20 mg/CE 0.45 mg<br> | Drug: Bazedoxifene 20 mg/CE 0.45 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Bazedoxifene 40 mg/CE 0.45 mg<br> | Drug: Bazedoxifene 40 mg/CE 0.45 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Raloxifene 60 mg<br> | Drug: Raloxifene 60 mg<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as raloxifene tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|
| Placebo<br> | Drug: Placebo<br>* No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as placebo capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups |  | Baseline, 6 months and 24 months |