NCT02100137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

4.2 years

First QC Date

March 5, 2012

Last Update Submit

March 26, 2014

Conditions

Endometrial Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

Women with endometrial hyperplasia

Other: vaginal ultrasound

Interventions

vaginal ultrasoundOTHER

vaginal ultrasound performed at a routine gyn examination

Women with endometrial hyperplasia

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

You may qualify if:

  • asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound

You may not qualify if:

  • postmenopausal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lukas Hefler, Associate Professor

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 31, 2014

Study Start

September 1, 2006

Primary Completion

November 1, 2010

Study Completion

July 1, 2012

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

AU(1)