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

Recruitingn/aAges 20 Years - 50 YearsFemaleSCHETTINI SERGIO
NCT07478614 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 debat

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📋 Eligibility rules (as published)
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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What it tests

  • This is a non-interventional study. Treatment allocation will not be influenced by the study protocol.
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Where

1 site
Ospedale San Carlo
Potenza, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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