Women With Asymptomatic Endometrial Hyperplasia

Endometrial Hyperplasia Clinical Trial

— FAME-ENDO  

Official title:

Women With Asymptomatic Endometrial Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100137
• Other study ID #: AGO 12
• Secondary ID: AGO Austria
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: March 26, 2014
• Start date: September 2006
• Est. completion date: July 2012

Study information

• Verified date: March 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

Exclusion Criteria:

• postmenopausal bleeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia

Intervention

Other:
• vaginal ultrasound
vaginal ultrasound performed at a routine gyn examination

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of invasive endometrial cancers		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	No
Secondary	Number of women with atypical endometrial hyperplasia		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	No