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Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort


Phase 1/Phase 2
45 Years
75 Years
Not Enrolling
Female
Endometrial Hyperplasia

Thank you

Trial Information

Development of a Screening Test for Endometrial Hyperplasia in an At Risk Cohort


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.


Inclusion Criteria:



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

Exclusion Criteria:

- Women who have had a hysterectomy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Endometrial Hyperplasia

Outcome Description:

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.

Outcome Time Frame:

End of study

Safety Issue:

No

Principal Investigator

Richard Legro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

20175

NCT ID:

NCT00123188

Start Date:

April 2005

Completion Date:

September 2009

Related Keywords:

  • Endometrial Hyperplasia
  • Endometrial Hyperplasia
  • Hyperplasia
  • Adenoma

Name

Location
Penn State Milton S. Hershey Hershey, Pennsylvania  17033