Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis (Adenomyosis)

March 13, 2026 updated by: SCHETTINI SERGIO

The primary objective of this multicenter observational cohort study is to evaluate the current medical approach to the management of adenomyosis in women, with particular focus on treatment selection and treatment persistence. The secondary objective is to identify the criteria guiding therapeutic choices in daily clinical practice within a multicenter setting.

Adenomyosis is a benign gynecological condition characterized by the presence of endometrial-like epithelial and stromal tissue within the myometrium. It mainly affects women aged 41 to 45 years and typically presents with symptoms such as chronic pelvic pain, dysmenorrhea, and menorrhagia. The most commonly used treatments include GnRH agonists, progestins, and intrauterine devices (IUDs); however, there are no universally accepted guidelines for the management of this condition, and therapeutic options remain a matter of debate.

This is a multicenter observational cohort study with both prospective and retrospective recruitment of women affected by adenomyosis. Italian clinical centers will be included and will recruit patients aged between 20 and 50 years, with a diagnosis of adenomyosis confirmed by ultrasound or magnetic resonance imaging (MRI) and/or histology, and presenting significant symptoms (VAS ≥ 4 for pelvic pain or bleeding > 100 on the Pictorial Blood Assessment Chart - PBAC). Cases of concomitant endometriosis, pregnancy, and conditions preventing informed consent will be excluded.

Each center will collect data regarding the prescribed treatment, its effectiveness, and treatment persistence over time. The study duration will be 12 months, with data collection at baseline (V0), 3 months (V1), 6 months (V2), and 12 months (V3). Approximately 200 patients will be enrolled across 20 centers, with an enrollment period of 12 months.

The analysis will be conducted based on the frequency of treatment use and changes in treatment response in relation to age, symptoms, and other clinical factors.

Data Collection Methodology

Patients will undergo regular clinical evaluations at 3 months, 6 months, and 12 months. Data will be collected using validated questionnaires (VAS, PBAC, SF-12). Transvaginal ultrasound examinations will be performed, and ferritin and hemoglobin levels will be measured. Treatment adherence and tolerability will be monitored through interviews and the recording of adverse events (AEs), including serious adverse events (SAEs).

Data Analysis

The analysis will be descriptive, focusing on the frequency of prescribed treatments and patient characteristics (age, symptoms, comorbidities). Continuous variables will be analyzed using mean and standard deviation (for normally distributed data) or median and range (for non-normally distributed data), while categorical variables will be analyzed using proportions and 95% confidence intervals. Differences between groups will be explored using appropriate statistical tests.

Expected Results and Implications

This study will provide crucial information on the epidemiology of therapeutic approaches to adenomyosis in Italy, helping to bridge existing knowledge gaps and supporting the development of evidence-based recommendations for clinical management. The results will help guide medical practice, improve patients' quality of life, and contribute to the development of therapeutic guidelines.

Dissemination of Results

The study results will be published in scientific articles in international peer-reviewed journals, with active participation of the physicians involved in the research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Female patients aged between 20 and 50 years, symptomatic for adenomyosis, with a confirmed diagnosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiology of Therapeutic Strategies in Patients with Adenomyosis
Time Frame: Outcomes will be recorded at treatment initiation (baseline) and at 3, 6, and 12 months.
To evaluate the current medical approach to the management of adenomyosis in women, with particular focus on treatment selection and treatment persistence.
Outcomes will be recorded at treatment initiation (baseline) and at 3, 6, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCHETTINI SERGIO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

February 18, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240046096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Diseases

Clinical Trials on This is a non-interventional study. Treatment allocation will not be influenced by the study protocol.

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