We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound and Endometrial Hyperplasia

This study has been terminated.
(enrollment of participants has halted prematurely; difficulty with recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123188
First Posted: July 22, 2005
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Center for Research on Women and Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
  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
Endometrial Hyperplasia Procedure: Ultrasound and Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort

Resource links provided by NLM:


Further study details as provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Endometrial Hyperplasia [ Time Frame: End of study ]
    A transvaginal ultrasound of the endometrium will be performed to obtain measures of the anteroposterior endometrial thickness (in the sagittal plane), the dimensions of the endometrial cavity (thickness, length and width), and the appearance of the endometrium in addition to uterine and ovarian measures. Endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with the metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.


Secondary Outcome Measures:
  • Endometrial Cancer [ Time Frame: End of study ]
    All women will then undergo an endometrial biopsy. The pipelle has been shown to be an accurate method of diagnosing endometrial cancer comparable to a full dilatation and curettage of the uterus. We believe it is important to perform a biopsy even in women with a thin endometrial stripe (<5mm), as it will be important for determining the specificity and negative predictive value of both ultrasound and any serum screening strategy we devise.


Enrollment: 36
Study Start Date: April 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound and Biopsy
Transvaginal Ultrasound and Endometrial Biopsy
Procedure: Ultrasound and Biopsy
Transvaginal ultrasound and Endometrial Biopsy

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123188


Locations
United States, Pennsylvania
Penn State Milton S. Hershey
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Center for Research on Women and Health
Investigators
Principal Investigator: Richard Legro, M.D. Penn State College of Medicine
  More Information

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00123188     History of Changes
Other Study ID Numbers: 20175
First Submitted: July 20, 2005
First Posted: July 22, 2005
Last Update Posted: January 19, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hyperplasia
Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female