Women With Asymptomatic Endometrial Hyperplasia (FAME-ENDO)

March 26, 2014 updated by: LHefler, Medical University of Vienna
The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Description

Inclusion Criteria:

  • asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Exclusion Criteria:

  • postmenopausal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with endometrial hyperplasia
Other: vaginal ultrasound
vaginal ultrasound performed at a routine gyn examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of invasive endometrial cancers
Time Frame: Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days
Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of women with atypical endometrial hyperplasia
Time Frame: Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days
Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Lukas Hefler, Associate Professor, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 26, 2014

First Posted (ESTIMATE)

March 31, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO 12
  • AGO Austria (OTHER: AGO Austria)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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