Observational Study Analyzing RNA Expression Of Endometri... | NCT00847821

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

NCT00847821

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Terminated

Last Update Posted

Sep 6, 2010Estimated

Enrollment

185Actual

Phase

Not provided

Conditions

Postmenopause

Interventions

Bazedoxifene 10 mg/CE 0.625 mg
Bazedoxifene 20 mg/CE 0.625 mg
Bazedoxifene 40 mg/CE 0.625 mg
Bazedoxifene 10 mg/CE 0.45 mg
Bazedoxifene 20 mg/CE 0.45 mg
Bazedoxifene 40 mg/CE 0.45 mg
Raloxifene 60 mg
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
B2311003

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See termination reason in detailed description.

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 18, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2010

Last Update Posted Date

Sep 6, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

185Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bazedoxifene 10 mg/CE 0.625 mg			Drug: Bazedoxifene 10 mg/CE 0.625 mg
Bazedoxifene 20 mg/CE 0.625 mg			Drug: Bazedoxifene 20 mg/CE 0.625 mg
Bazedoxifene 40 mg/CE 0.625 mg			Drug: Bazedoxifene 40 mg/CE 0.625 mg
Bazedoxifene 10 mg/CE 0.45 mg			Drug: Bazedoxifene 10 mg/CE 0.45 mg
Bazedoxifene 20 mg/CE 0.45 mg			Drug: Bazedoxifene 20 mg/CE 0.45 mg
Bazedoxifene 40 mg/CE 0.45 mg			Drug: Bazedoxifene 40 mg/CE 0.45 mg
Raloxifene 60 mg			Drug: Raloxifene 60 mg
Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bazedoxifene 10 mg/CE 0.625 mg	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups		Baseline, 6 months and 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Fort Myers	Florida	33916	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D013629	Tamoxifen
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals