See termination reason in detailed description.
RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
Sponsor study identifier
Secondary identifiers
observational
185
1 country
22
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 18, 2009
Actual (reported)February 19, 2009
Actual (reported)May 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 2010
Actual (reported)August 2010
Actual (reported)Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
Baseline, 6 months and 24 months
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.
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.
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.
Pfizer Investigational Site
Fort Myers, Florida, 33916, United States
Pfizer Investigational Site
Gainesville, Florida, 32606, United States
Pfizer Investigational Site
New Port Richey, Florida, 34652, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536, United States
Endometrial biopsy blocks
Pfizer CT.gov Call Center
Pfizer
185 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
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.
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.
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.
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.
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.
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.
Contact the study team to confirm eligibility.
Pfizer Investigational Site
Louisville, Kentucky, 40291, United States
Pfizer Investigational Site
Southfield, Michigan, 48034, United States
Pfizer Investigational Site
Chaska, Minnesota, 55318, United States
Pfizer Investigational Site
Billings, Montana, 59102, United States
Pfizer Investigational Site
New Brunswick, New Jersey, 08901, United States
Pfizer Investigational Site
Las Vegas, New Mexico, 89416, United States
Pfizer Investigational Site
Rochester, New York, 14642, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45267, United States
Pfizer Investigational Site
Wexford, Pennsylvania, 15090, United States
Pfizer Investigational Site
Greenville, South Carolina, 29605, United States
Pfizer Investigational Site
Dallas, Texas, 75390, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Charlottesville, Virginia, 22903, United States
Pfizer Investigational Site
Norfolk, Virginia, 23507, United States
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
September 6, 2010
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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