A multinational Post-Authorisation Safety Study evaluating real-world treatment in patients receiving Yselty® (linzagolix choline) for moderate to severe symptoms of uterine fibroids - DAISY

Study identification

• EU PAS number:
  EUPAS1000000924
• Study ID:
  1000000924
• Official title and acronym:
  A multinational Post-Authorisation Safety Study evaluating real-world treatment in patients receiving Yselty® (linzagolix choline) for moderate to severe symptoms of uterine fibroids - DAISY
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  Post-Authorization Safety Study to assess the long-term safety of Yselty® when used in real life clinical practice.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:23/05/2025

Actual:23/05/2025

Study start date

Planned:15/03/2026

Data analysis start date

Planned:15/01/2028

Date of interim report, if expected

Planned:30/12/2028

Date of final study report

Planned:31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Theramex Ireland Limited

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)