| Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
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| RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
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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.
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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.
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| Observational
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Observational Model: Cohort
Time Perspective: Retrospective
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| Not Provided
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Retention: Samples With DNA
Description:
Endometrial biopsy blocks
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| Non-Probability Sample
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| Postmenopausal women who participated in and completed the 3115A1-303 study, were at least 80% compliant with test article administration during the study, and have provided a new signed and written informed consent for study 3115A1-1125.
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| Postmenopause
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- Drug: Bazedoxifene 10 mg/CE 0.625 mg
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.
- Drug: Bazedoxifene 20 mg/CE 0.625 mg
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.
- Drug: Bazedoxifene 40 mg/CE 0.625 mg
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.
- Drug: Bazedoxifene 10 mg/CE 0.45 mg
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.
- Drug: Bazedoxifene 20 mg/CE 0.45 mg
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.
- Drug: Bazedoxifene 40 mg/CE 0.45 mg
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.
- Drug: Raloxifene 60 mg
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.
- Drug: Placebo
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.
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- Bazedoxifene 10 mg/CE 0.625 mg
Intervention: Drug: Bazedoxifene 10 mg/CE 0.625 mg
- Bazedoxifene 20 mg/CE 0.625 mg
Intervention: Drug: Bazedoxifene 20 mg/CE 0.625 mg
- Bazedoxifene 40 mg/CE 0.625 mg
Intervention: Drug: Bazedoxifene 40 mg/CE 0.625 mg
- Bazedoxifene 10 mg/CE 0.45 mg
Intervention: Drug: Bazedoxifene 10 mg/CE 0.45 mg
- Bazedoxifene 20 mg/CE 0.45 mg
Intervention: Drug: Bazedoxifene 20 mg/CE 0.45 mg
- Bazedoxifene 40 mg/CE 0.45 mg
Intervention: Drug: Bazedoxifene 40 mg/CE 0.45 mg
- Raloxifene 60 mg
Intervention: Drug: Raloxifene 60 mg
- Placebo
Intervention: Drug: Placebo
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| Not Provided
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| Terminated
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| 185
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| 400
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| August 2010
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| August 2010 (Final data collection date for primary outcome measure)
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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)
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| Sexes Eligible for Study: |
Female |
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| 40 Years to 75 Years (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| United States
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| NCT00847821
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3115A1-1125
B2311003
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| No
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| Not Provided
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| Not Provided
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| Director, Clinical Trial Disclosure Group, Pfizer, Inc
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| Wyeth is now a wholly owned subsidiary of Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Wyeth is now a wholly owned subsidiary of Pfizer
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| September 2010
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