Ultrasound Characterization of Postmenopausal Endometriosis (ENDO-MENOPAUSA)

September 3, 2026 updated by: Simone Ferrero

Prevalence and Ultrasound Characterization of Endometriosis in Postmenopausal Women Undergoing Routine Gynecological Examination

Endometriosis is traditionally considered a disease of reproductive-age women; however, residual lesions may persist after menopause and be detectable at imaging. The prevalence and sonographic characteristics of such findings in postmenopausal women remain poorly defined.

This prospective observational study aims to assess the prevalence and ultrasonographic features of findings suggestive of deep endometriosis and endometrioma-like cysts in postmenopausal women undergoing routine gynecological examination using a standardized transvaginal ultrasound protocol. The study also explores clinical factors associated with these findings to improve interpretation and clinical management in this population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective observational study including consecutive postmenopausal women attending gynecological outpatient clinics for routine evaluation. Participants undergo a standardized transvaginal ultrasound performed by an expert operator according to the International Deep Endometriosis Analysis (IDEA) group criteria, with systematic assessment of pelvic compartments and soft markers.

Ultrasound findings suggestive of deep endometriosis and/or endometrioma-like cysts are recorded and morphologically characterized. Clinical data, including demographic variables, reproductive history, pain symptoms during reproductive life, and hormonal exposure after menopause, are collected using a structured questionnaire and medical records.

The primary objective is to determine the prevalence and describe the sonographic phenotype of suspected endometriosis-related findings in postmenopausal women. Secondary objectives include identifying clinical factors associated with these findings through multivariable analysis and improving the differentiation between benign residual lesions and clinically relevant or suspicious pathology in this setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

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

  • Italy
    • Ge
      • Chiavari, Ge, Italy, 16033
        • ASL-4 Liguria

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation.

Description

INCLUSION CRITERIA

  • Postmenopausal status, defined by at least 12 consecutive months of spontaneous amenorrhea not attributable to pregnancy, lactation, medical therapy, or other pathological causes, or, when clinically required, by biochemical evidence consistent with menopause based on a serum FSH level >25 IU/L.
  • Attendance at participating gynecological outpatient clinics for routine examination
  • Ability to undergo transvaginal ultrasound examination
  • Ability to provide informed consent

EXCLUSION CRITERIA

  • Previous surgical and/or radiological diagnosis of endometriosis
  • History of hysterectomy and/or bilateral oophorectomy (any surgical approach)
  • Active pelvic malignancy at the time of enrollment
  • Inability to undergo or tolerate transvaginal ultrasound examination (e.g., severe introital stenosis, vaginismus, or never sexually active)
  • Non-interpretable ultrasound examination due to technical limitations

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Postmenopausal women
The study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation
Procedure: Anamnesis
Collection fo clinical data
Procedure: Ultrasonographic evaluation
Ultrasonographic evaluation according to stardardized criteria for detecting endometriosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of ultrasound findings suggestive of deep endometriosis in postmenopausal women
Time Frame: Baseline
Proportion of postmenopausal women presenting at least one ultrasound finding suggestive of deep endometriosis and/or endometrioma-like cysts, as assessed by standardized transvaginal ultrasound according to the International Deep Endometriosis Analysis (IDEA) criteria.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasonographic characteristics of endometriosis-like lesions
Time Frame: Baseline
Morphological description of ultrasound findings suggestive of deep endometriosis, including lesion size, margins, echotexture, vascularization, and anatomical distribution within pelvic compartments
Baseline
Association between ultrasound findings and reproductive-age symptoms
Time Frame: Baseline
Association between the presence of ultrasound findings suggestive of endometriosis and history of dysmenorrhea, chronic pelvic pain, dyspareunia, and infertility during reproductive life.
Baseline
Association between ultrasound findings and time since menopause
Time Frame: Baseline
Evaluation of the relationship between time elapsed since menopause and the presence of ultrasound findings suggestive of deep endometriosis.
Baseline
Association between ultrasound findings and hormonal exposure
Time Frame: Baseline
Assessment of the association between ultrasound findings suggestive of endometriosis and current or past use of hormone replacement therapy or local estrogen therapy.
Baseline
Prevalence of endometrioma-like ovarian cysts
Time Frame: Baseline
Proportion of postmenopausal women presenting ovarian cysts with ultrasound features suggestive of endometriomas, including typical and atypical morphology.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Simone Ferrero

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ASL4-Liguria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENDO-MENOPAUSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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