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Women With Asymptomatic Endometrial Hyperplasia (FAME-ENDO)

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ClinicalTrials.gov Identifier: NCT02100137
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
LHefler, Medical University of Vienna

Brief Summary:
The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.

Condition or disease Intervention/treatment
Endometrial Hyperplasia Other: vaginal ultrasound

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women With Asymptomatic Endometrial Hyperplasia
Study Start Date : September 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : July 2012

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
Criteria

Inclusion Criteria:

  • asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Exclusion Criteria:

  • postmenopausal bleeding

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): NCT02100137


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Lukas Hefler, Associate Professor Medical University of Vienna

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Responsible Party: LHefler, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02100137     History of Changes
Other Study ID Numbers: AGO 12
AGO Austria ( Other Identifier: AGO Austria )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female