Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting

Study Overview
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Brief Summary
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This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

Detailed Description
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This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies. It is planned to enrol approximately 1,500 patients. Consecutive, eligible, patients will be invited to enrol from approximately 100-150 European Union (EU) clinical practice sites in approximately 15 countries. Patients will be followed for an observation period of 60 months (5 years) from treatment start. Investigators are to manage and treat patients according to their standard medical practice.

Official Title
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Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.

Conditions
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Uterine Fibroids

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women of reproductive age with a diagnosis of moderate to severe symptoms of uterine fibroids who are not eligible for surgery and for whom a intermittent treatment with Esmya in a long term manner (at least 2 courses), is planned or subjects who were exposed to UPA 5 or 10 mg during long term Phase III trials PGL09-027 (PEARL III extension, including patients (PEARL extension 2)) or PGL11-006 (PEARL IV), and Patient is willing and able to attend visits which are scheduled by her treating physician for the regular follow-up, provide the required medical data, and Patient has personally signed and dated the informed consent document indicating that she has been informed of all pertinent aspects of the study. Exclusion criteria: Patient is prescribed Esmya for pre-operative treatment Patient has a contraindication to receive Esmya as per SmPC Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrolment, Patient has hypersensitivity to the active substance of Esmya or to one of its excipients, Not applicable to long term phase III previous subjects who are not planning to receive Esmya during this study: Patient is pregnant or plans to become pregnant within the next 12 months from treatment start, Patient is breastfeeding, Patient has genital bleeding of unknown aetiology or not due to uterine fibroids, Patient has been diagnosed with uterine, cervical, ovarian or breast cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with Esmya<br>Any patient who was confirmed as receiving one dose of Esmya | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of long term safety: Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation | Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation | Patients will be followed from baseline up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Prescription pattern of Esmya in standard medical practice | Esmya use in patients | Patients will be followed from baseline up to 60 months |