- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847821
Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
September 3, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
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.
Study Overview
Status
Terminated
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
185
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33916
- Pfizer Investigational Site
-
Gainesville, Florida, United States, 32606
- Pfizer Investigational Site
-
New Port Richey, Florida, United States, 34652
- Pfizer Investigational Site
-
West Palm Beach, Florida, United States, 33409
- Pfizer Investigational Site
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- Pfizer Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60610
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Pfizer Investigational Site
-
Louisville, Kentucky, United States, 40291
- Pfizer Investigational Site
-
-
Michigan
-
Southfield, Michigan, United States, 48034
- Pfizer Investigational Site
-
-
Minnesota
-
Chaska, Minnesota, United States, 55318
- Pfizer Investigational Site
-
-
Montana
-
Billings, Montana, United States, 59102
- Pfizer Investigational Site
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Pfizer Investigational Site
-
-
New Mexico
-
Las Vegas, New Mexico, United States, 89416
- Pfizer Investigational Site
-
-
New York
-
Rochester, New York, United States, 14642
- Pfizer Investigational Site
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27609
- Pfizer Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- Pfizer Investigational Site
-
-
Pennsylvania
-
Wexford, Pennsylvania, United States, 15090
- Pfizer Investigational Site
-
-
South Carolina
-
Greenville, South Carolina, United States, 29605
- Pfizer Investigational Site
-
-
Texas
-
Dallas, Texas, United States, 75390
- Pfizer Investigational Site
-
San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Pfizer Investigational Site
-
Norfolk, Virginia, United States, 23507
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
Time Frame: Baseline, 6 months and 24 months
|
Baseline, 6 months and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
February 18, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 19, 2009
Study Record Updates
Last Update Posted (Estimate)
September 6, 2010
Last Update Submitted That Met QC Criteria
September 3, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3115A1-1125
- B2311003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postmenopause
-
Merck Sharp & Dohme LLCCompleted
-
Wageningen UniversityCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Wageningen UniversityCompleted
-
Tel-Aviv Sourasky Medical CenterAmorphical Ltd.Unknown
-
Wyeth is now a wholly owned subsidiary of PfizerMDS Pharma ServicesCompletedPostmenopauseUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedPostmenopause
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedPostmenopauseUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedPostmenopauseUnited States
Clinical Trials on Bazedoxifene 10 mg/CE 0.625 mg
-
PfizerCompletedWeight Management | Treatment Of ObesityCanada, United States, Bulgaria, Spain, Mexico, India, Puerto Rico
-
PfizerCompletedOsteoporosisUnited States, Norway, Brazil, Netherlands
-
Alvogen KoreaUnknown
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
PfizerCompletedMenopause | OsteoporosisUnited States, Colombia, Australia, Hungary, Poland, Finland, Argentina, Chile, Denmark, Mexico, New Zealand, Norway
-
CrossjectCompleted
-
PfizerCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Vigonvita Life SciencesCompleted
-
Idorsia Pharmaceuticals Ltd.Completed