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Completed

NCT Number: NCT07503938

Ultrasound Characterization of Postmenopausal Endometriosis

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ASL-4 Liguria

Chiavari, Ge, 16033, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anamnesis

Procedure

Collection fo clinical data

Ultrasonographic evaluation

Procedure

Ultrasonographic evaluation according to stardardized criteria for detecting endometriosis

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Simone Ferrero

Other

Collaborators

  • ASL4-Liguria

Registry information

Official study title

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

Acronym: ENDO-MENOPAUSA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.