ASL-4 Liguria
Chiavari, Ge, 16033, Italy
NCT Number: NCT07503938
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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Notify Me50 year and older
Female
Observational
Chiavari, Ge, 16033, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Collection fo clinical data
Ultrasonographic evaluation according to stardardized criteria for detecting endometriosis
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.
Time frame: Baseline
Morphological description of ultrasound findings suggestive of deep endometriosis, including lesion size, margins, echotexture, vascularization, and anatomical distribution within pelvic compartments
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.
Time frame: Baseline
Evaluation of the relationship between time elapsed since menopause and the presence of ultrasound findings suggestive of deep endometriosis.
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.
Time frame: Baseline
Proportion of postmenopausal women presenting ovarian cysts with ultrasound features suggestive of endometriomas, including typical and atypical morphology.
Simone Ferrero
Other
Prevalence and Ultrasound Characterization of Endometriosis in Postmenopausal Women Undergoing Routine Gynecological Examination
Acronym: ENDO-MENOPAUSA
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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.