Ultrasound and Endometrial Hyperplasia

NCT ID: NCT00123188

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-09-30

Brief Summary

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The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.

Detailed Description

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The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort. Endometrial carcinoma is an understudied cancer. This study will provide benefit regardless of its outcome, because it will be the first prospectively designed screening trial in an asymptomatic population.

Conditions

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Endometrial Hyperplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound and Biopsy

Transvaginal Ultrasound and Endometrial Biopsy

Group Type EXPERIMENTAL

Ultrasound and Biopsy

Intervention Type PROCEDURE

Transvaginal ultrasound and Endometrial Biopsy

Interventions

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Ultrasound and Biopsy

Transvaginal ultrasound and Endometrial Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension

Exclusion Criteria

* Women who have had a hysterectomy
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Research on Women and Health

UNKNOWN

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State Milton S. Hershey

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20175

Identifier Type: -

Identifier Source: org_study_id

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