Ultrasound and Endometrial Hyperplasia

This study is currently recruiting participants.

Verified by Penn State University, April 2008

Sponsors and Collaborators:	Penn State University Center for Research on Women and Health
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00123188

Purpose

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.

Condition	Intervention	Phase
Endometrial Hyperplasia	Procedure: Ultrasound	Phase I Phase II

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort

Further study details as provided by Penn State University:

Primary Outcome Measures:

The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort

Secondary Outcome Measures:

The researchers propose that this metabolic syndrome is also a risk factor for endometrial hyperplasia and cancer

Estimated Enrollment:	100
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Women who have had a hysterectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123188

Contacts

Contact: Sandy Eyer

717-531-1540

seyer@psu.edu

Locations

United States, Pennsylvania
Penn State Milton S. Hershey	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sandy Eyer 717-531-1540 seyer@psu.edu
Principal Investigator: Richard Legro, M.D.

Sponsors and Collaborators

Penn State University

Center for Research on Women and Health

Investigators

Principal Investigator:

Richard Legro, M.D.

Penn State College of Medicine

More Information

Responsible Party:	The ( Center for Research on Women and Health )
Study ID Numbers:	20175
Study First Received:	July 20, 2005
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00123188
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Hyperplasia
Uterine Diseases
Endometrial Hyperplasia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009