Postmenopausal EndometriosisENDO-MENOPAUSANCT07503938
Ultrasound Characterization of Postmenopausal Endometriosis
An observational study of Postmenopausal Endometriosis, run by Simone Ferrero at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Endometriosis
- What is being tested?
- Anamnesis and Ultrasonographic evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 492 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postmenopausal Endometriosis
- Being tested
- Anamnesis, Ultrasonographic evaluation
- Keywords
- Postmenopausal endometriosis, Transvaginal ultrasound, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnamnesisProcedure or surgery
Collection fo clinical data
Ultrasonographic evaluationProcedure or surgery
Ultrasonographic evaluation according to stardardized criteria for detecting endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women | The study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation Receives: Procedure: Anamnesis; Procedure: Ultrasonographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Ultrasonographic characteristics of endometriosis-like lesions
Morphological description of ultrasound findings suggestive of deep endometriosis, including lesion size, margins, echotexture, vascularization, and anatomical distribution within pelvic compartments
Measured: Baseline
Association between ultrasound findings and reproductive-age symptoms
Association between the presence of ultrasound findings suggestive of endometriosis and history of dysmenorrhea, chronic pelvic pain, dyspareunia, and infertility during reproductive life.
Measured: Baseline
Association between ultrasound findings and time since menopause
Evaluation of the relationship between time elapsed since menopause and the presence of ultrasound findings suggestive of deep endometriosis.
Measured: Baseline
Association between ultrasound findings and hormonal exposure
Assessment of the association between ultrasound findings suggestive of endometriosis and current or past use of hormone replacement therapy or local estrogen therapy.
Measured: Baseline
Prevalence of endometrioma-like ovarian cysts
Proportion of postmenopausal women presenting ovarian cysts with ultrasound features suggestive of endometriomas, including typical and atypical morphology.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Jun 2023
- Primary completion30 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simone Ferrero
- Sponsor type
- University, hospital or other
- Collaborators
- ASL4-Liguria
- Responsible party
- Sponsor-investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503938
- Sponsor's protocol ID
- ENDO-MENOPAUSA
- Acronym
- ENDO-MENOPAUSA
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27349699Vallee 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.
PubMed 38531006
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Ultrasound Characterization of Endometriosis in Postmenopausal Women Undergoing Routine Gynecological Examination
- ClinicalTrials.gov ID
- NCT07503938
- Acronym / sponsor ID
- ENDO-MENOPAUSA / ENDO-MENOPAUSA
- Conditions
- Postmenopausal Endometriosis
- Keywords
- Postmenopausal endometriosis, Transvaginal ultrasound, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Simone FerreroUniversity, hospital or other
- Collaborators
- ASL4-Liguria
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women | – | Procedure: Anamnesis, Procedure: Ultrasonographic evaluationThe study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of consecutive postmenopausal women attending gynecological outpatient clinics for routine clinical evaluation.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnamnesisCollection fo clinical data | Procedure or surgery | Postmenopausal women |
| Ultrasonographic evaluationUltrasonographic evaluation according to stardardized criteria for detecting endometriosis | Procedure or surgery | Postmenopausal women |
Primary outcome
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.
5 secondary outcomes
Ultrasonographic characteristics of endometriosis-like lesions
Time frame: Baseline
Association between ultrasound findings and reproductive-age symptoms
Time frame: Baseline
Association between ultrasound findings and time since menopause
Time frame: Baseline
Association between ultrasound findings and hormonal exposure
Time frame: Baseline
Prevalence of endometrioma-like ovarian cysts
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 27349699Guerriero 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.
- Background: PubMed 38531006Vallee 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Endometriosis, run by Simone Ferrero at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ultrasound findings suggestive of deep endometriosis in postmenopausal women (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.