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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00847821
First received: February 18, 2009
Last updated: September 3, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Postmenopause
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
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Endometrial biopsy blocks


Enrollment: 185
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bazedoxifene 10 mg/CE 0.625 mg 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.
Bazedoxifene 20 mg/CE 0.625 mg 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.
Bazedoxifene 40 mg/CE 0.625 mg 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.
Bazedoxifene 10 mg/CE 0.45 mg 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.
Bazedoxifene 20 mg/CE 0.45 mg 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.
Bazedoxifene 40 mg/CE 0.45 mg 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.
Raloxifene 60 mg 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.
Placebo 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847821

  Show 22 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00847821     History of Changes
Other Study ID Numbers: 3115A1-1125, B2311003
Study First Received: February 18, 2009
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Raloxifene
Bazedoxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014