DAISY
Research type
Research Study
Full title
A multinational Post-Authorisation Safety Study evaluating real-world treatment in patients receiving Yselty® (linzagolix choline) for moderate to severe symptoms of uterine fibroids
IRAS ID
363973
Contact name
Funlayo Odejinmi
Contact email
Sponsor organisation
Theramex Ireland Limited
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
This is a non-interventional, prospective, multicentre, multinational, cohort study sponsored by Theramex Ireland Ltd and required from the European Medicines Agency (EMA). The study will be conducted in 5 European countries (Germany, Italy, Spain, Poland and UK) and is aiming to assess the long-term safety of Yselty® (linzagolix) in treating women with uterine fibroids in real-world clinical practice.
Uterine fibroids, common in reproductive-age women, often cause debilitating symptoms like heavy menstrual bleeding (HMB). While various treatment options exist, many have limitations, and recurrence is frequent. Yselty® is a hormonal medication that works by blocking certain hormones in the body to lower estrogen levels. Estrogen is a hormone that can cause the growth of uterine fibroids, which are non-cancerous growths in the uterus. By reducing estrogen, Yselty® helps decrease the fibroids and relieve symptoms like heavy menstrual bleeding (HMB). However, its long-term safety, especially regarding bone mineral density (BMD) and other side effects, remains insufficiently studied.
The study will evaluate BMD changes over time and monitor the incidence of osteoporosis, fractures, liver enzyme abnormalities, mood disorders, and other health conditions linked to long-term Yselty® use. It will also assess treatment adherence and physician compliance with recommended guidelines, including BMD monitoring. The study will provide real-world insights into the safety profile of Yselty®, informing clinical decisions and patient management strategies for long-term use.
The study will include about 1,000 women with documented uterine fibroids, therapy-naïve to Yselty®, and who meet the criteria for treatment defined in the Summary of Product Characteristics (SmPC) for prescription in the respective country. The decision to treat with Yselty® will not be influenced by study inclusion.
Data will be collected from routine clinical visits, starting around the beginning of 2026 and will last up to 48 months.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0234
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion