NCT07478614 Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2025-06-01 with a primary completion date of 2026-02-18.

Brief Summary

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.

Eligibility 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.

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