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

Wyeth

Status: Terminated

Conditions: Postmenopause

Treatments: Drug: Bazedoxifene 10 mg/CE 0.625 mg; Drug: Bazedoxifene 20 mg/CE 0.45 mg; Drug: Bazedoxifene 40 mg/CE 0.625 mg; Drug: Bazedoxifene 10 mg/CE 0.45 mg; Drug: Bazedoxifene 20 mg/CE 0.625 mg; Drug: Bazedoxifene 40 mg/CE 0.45 mg; Drug: Raloxifene 60 mg; Drug: Placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT00847821

B2311003

3115A1-1125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

185 participants in 8 patient groups

Bazedoxifene 10 mg/CE 0.625 mg

Treatment:

Drug: Bazedoxifene 10 mg/CE 0.625 mg

Bazedoxifene 20 mg/CE 0.625 mg

Treatment:

Drug: Bazedoxifene 20 mg/CE 0.625 mg

Bazedoxifene 40 mg/CE 0.625 mg

Treatment:

Drug: Bazedoxifene 40 mg/CE 0.625 mg

Bazedoxifene 10 mg/CE 0.45 mg

Treatment:

Drug: Bazedoxifene 10 mg/CE 0.45 mg

Bazedoxifene 20 mg/CE 0.45 mg

Treatment:

Drug: Bazedoxifene 20 mg/CE 0.45 mg

Bazedoxifene 40 mg/CE 0.45 mg

Treatment:

Drug: Bazedoxifene 40 mg/CE 0.45 mg

Raloxifene 60 mg

Treatment:

Drug: Raloxifene 60 mg

Placebo

Treatment:

Drug: Placebo