Endometrial HyperplasiaFAME-ENDONCT02100137
Women With Asymptomatic Endometrial Hyperplasia
An observational study of Endometrial Hyperplasia, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Hyperplasia
- What is being tested?
- vaginal ultrasound
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2006to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
Who may be able to join
- asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
Who cannot join
- postmenopausal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.
- Conditions
- Endometrial Hyperplasia
- Being tested
- vaginal ultrasound
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal ultrasoundOther
vaginal ultrasound performed at a routine gyn examination
| Study group | Role | What they receive |
|---|---|---|
| Women with endometrial hyperplasia | Not described Receives: Other: vaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of invasive endometrial cancers
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startSep 2006
- Primary completionNov 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LHefler, Medical University of Vienna
- Investigators
- Lukas Hefler, Associate Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100137
- Sponsor's protocol ID
- AGO 12
- Other IDs
- AGO Austria
- Acronym
- FAME-ENDO
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2012
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Asymptomatic Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT02100137
- Acronym / sponsor ID
- FAME-ENDO / AGO 12
- Conditions
- Endometrial Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with endometrial hyperplasia | – | Other: vaginal ultrasound |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
Key inclusion criteria (1 listed)
- asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound
Key exclusion criteria (1 listed)
- postmenopausal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal ultrasoundvaginal ultrasound performed at a routine gyn examination | Other | Women with endometrial hyperplasia |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
Related trials for Endometrial Hyperplasia
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Hefler, Associate Professor principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Hyperplasia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.