Ultrasound Characterization of Postmenopausal Endometriosis

NCT07503938 | Completed

• 1 other identifier: ENDO-MENOPAUSA
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postmenopausal Endometriosis

Keywords

Postmenopausal endometriosis; Transvaginal ultrasound; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Prevalence of ultrasound findings suggestive of deep endometriosis in postmenopausal women

  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 Outcomes (5)

• Ultrasonographic characteristics of endometriosis-like lesions

  Baseline

• Association between ultrasound findings and reproductive-age symptoms

  Baseline

• Association between ultrasound findings and time since menopause

  Baseline

• Association between ultrasound findings and hormonal exposure

  Baseline

• Prevalence of endometrioma-like ovarian cysts

  Baseline

Study Arms (1)

Postmenopausal women

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

Procedure: Anamnesis; Procedure: Ultrasonographic evaluation

Interventions

Anamnesis PROCEDURE

Collection fo clinical data

Postmenopausal women

Ultrasonographic evaluation PROCEDURE

Ultrasonographic evaluation according to stardardized criteria for detecting endometriosis

Postmenopausal women

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simone Ferrero: lead
• ASL4-Liguria: collaborator

Study Sites (1)

ASL-4 Liguria

Chiavari, Ge, 16033, Italy

Location

Related Publications (2)

• Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installe AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Goncalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferrero S, Leon M, Bignardi T, Holland T, Jurkovic D, Benacerraf B, Osuga Y, Somigliana E, Timmerman D. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955. Epub 2016 Jun 28.

  PMID: 27349699 BACKGROUND

• Vallee A, Carbonnel M, Ceccaldi PF, Feki A, Ayoubi JM. Postmenopausal endometriosis: a challenging condition beyond menopause. Menopause. 2024 May 1;31(5):447-456. doi: 10.1097/GME.0000000000002338. Epub 2024 Mar 23.

  PMID: 38531006 BACKGROUND

MeSH Terms

Interventions

Immunologic Memory

Intervention Hierarchy (Ancestors)

Adaptive Immunity; Immunity; Immune System Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 31, 2026
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 1, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

IT (1)