Ultrasound Characterization of Postmenopausal Endometriosis (ENDO-MENOPAUSA)

March 26, 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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of consecutive postmenopausal women aged 50 years or older attending gynecological outpatient clinics for routine clinical evaluation.

Description

INCLUSION CRITERIA

  • Women aged ≥50 years
  • Postmenopausal status, defined as ≥12 consecutive months of spontaneous amenorrhea not attributable to pregnancy, lactation, medical therapy, or other pathological causes
  • 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
Intervention / Treatment
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

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

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

Simone Ferrero

Collaborators

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)

June 1, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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