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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,527
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
Time frame: Patients will be followed from baseline up to 60 months
Assessment of Prescription pattern of Esmya in standard medical practice
Esmya use in patients
Time frame: Patients will be followed from baseline up to 60 months
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Brno, Czechia
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Private Practice
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