Current medical approaches for managing adenomyosis
Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis
The study will see which treatments women aged 20–50 with adenomyosis receive and how long they continue them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | San Carlo Public Hospital, Potenza, Italy Academic / other |
| Locations | 1 site (Potenza) |
| Trial ID | NCT07478614 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational cohort combining retrospective and prospective enrollment to document real-world therapeutic choices for adenomyosis. No treatments are assigned by the protocol; investigators record clinical, imaging, and treatment data and follow patients over time to capture treatment persistence. Inclusion requires imaging or histologic confirmation and significant symptoms (pain or heavy bleeding), while patients with endometriosis or pregnancy are excluded. Collected data will be analyzed to identify the criteria guiding treatment selection in routine clinical practice across centers.
Who should consider this trial
Good fit: Women aged 20–50 with an imaging or histological diagnosis of adenomyosis who have significant pain (VAS ≥4) and/or heavy menstrual bleeding (PBAC >100), can provide informed consent, and can be followed at a participating center.
Not a fit: Women with current or prior endometriosis, suspected or confirmed pregnancy, those unable to provide informed consent, or asymptomatic women/outside the age range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could clarify which commonly used treatments patients are most likely to continue and help guide clearer management recommendations for women with adenomyosis.
How similar studies have performed: Several observational cohorts have described patterns of care for adenomyosis, but randomized evidence and consensus on optimal treatment remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age between 20 and 50 years; Instrumental (ultrasound or MRI) and/or histological diagnosis of adenomyosis; Adenomyosis-associated pain with a VAS score ≥ 4 and/or presence of heavy menstrual bleeding (HMB) defined as a score \> 100 on the Pictorial Blood Assessment Chart (PBAC); Provision of written informed consent to participate in the study; Willingness to be followed at the participating center for the entire duration of the study. Exclusion Criteria: Current or previous clinical and/or instrumental diagnosis of endometriosis; Suspected or confirmed pregnancy; Inability to understand the purpose of the study and to provide informed consent.
Where this trial is running
Potenza
- Ospedale San Carlo — Potenza, Italy (Recruiting)
Study contacts
- Study coordinator: Sergio Schettini
- Email: schettini@icloud.com
- Phone: +39 335424088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.