Last updated on February 2018

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

Brief description of study

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.

The specific objectives of the study are to assess the long term safety, including endometrial safety, of Esmya in standard medical practice and the prescription patterns of Esmya in standard medical practice.

The exploratory objective is to assess patients' quality of life in a long-term treatment setting.

Clinical Study Identifier: NCT02748460

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Gynekologicka ordinace

Ceske Budejovice, Czech Republic
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