Study identification

EU PAS number

EUPAS16792

Study ID

28785

Official title and acronym

A prospective, multi-national, multicentre, non-interventional study to evaluate the long term safety of Esmya, in particular the endometrial safety, and the current prescription and management patterns of Esmya in a long term treatment setting

DARWIN EU® study

No

Study countries

Belgium
Czechia
Denmark
France
Germany
Hungary
Italy
Latvia
Lithuania
Netherlands
Poland
Portugal
Romania
Spain
Sweden
United Kingdom

Study 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 enroll approximately 1,500 patients. Consecutive, eligible, patients will be invited to enroll 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 status

Finalised
Research institutions and networks

Institutions

PregLem
First published:
01/02/2024
Institution
Multiple centres: 153 centres are involved in the study

Contact details

Daniela Ciobanu

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter Plc
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)