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

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NCT00847821

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Study Location
Pfizer Investigational Site
Fort Myers, Florida, 33916, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
Official Title RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Endometrial biopsy blocks
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.
Condition Postmenopause
Intervention
  • 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.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 31, 2010)		185
Original Estimated Enrollment
 (submitted: February 18, 2009)		400
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study:Female
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00847821
Other Study ID Numbers 3115A1-1125
B2311003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2010