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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.
Full description
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.
Enrollment
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Inclusion criteria
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:
1,500 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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