Ultrasound and Endometrial Hyperplasia

NCT00123188 | Terminated

• 1 other identifier: 20175
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Endometrial Hyperplasia

  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.

  End of study

Secondary Outcomes (1)

• Endometrial Cancer

  End of study

Study Arms (1)

Ultrasound and Biopsy

EXPERIMENTAL

Transvaginal Ultrasound and Endometrial Biopsy

Procedure: Ultrasound and Biopsy

Interventions

Ultrasound and Biopsy PROCEDURE

Transvaginal ultrasound and Endometrial Biopsy

Ultrasound and Biopsy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who have had a hysterectomy

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Center for Research on Women and Health: collaborator

Study Sites (1)

Penn State Milton S. Hershey

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

High-Energy Shock Waves; Biopsy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richard Legro, M.D.

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (1)