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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  YSELTY
• Study drug International non-proprietary name (INN) or common name:
  LINZAGOLIX CHOLINE
• Anatomical Therapeutic Chemical (ATC) code:
  (H01CC04) linzagolix

  linzagolix
• Medical condition to be studied:
  Leiomyoma

Population studied

• Short description of the study population:
  Adult women of reproductive age with moderate to severe symptoms of Uterine fibroids
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  Non-interventional, prospective, multicentre, multinational, cohort study based on primary data collection
• Main study objective:
  To evaluate routinely collected data on long-term safety (>12 months) in relation to BMD with use of Yselty® 200 mg (with ABT) and 100 mg (with and without ABT) dosing regimens
• Setting:
  Adult women in reproductive age with moderate to severe symptoms of Uterine fibroids recruited and enrolled in hospital settings qualified to conduct the study. The recruitment period is planned for 18 months starting from Q1/Q2 2026. The inclusion and exclusion criteria are : ; Inclusion criteria; • Signed informed consent; • Females of reproductive age ≥18 years; • New users of Yselty® (not longer than 3 months after treatment initiation); • Indication of moderate to severe symptoms of uterine fibroids; ; Exclusion criteria; • Patients who have ever used another GnRH antagonist (e.g., relugolix, elagolix) before enrolment; • Contraindications as per the approved SmPC; • Enrolment in a prior clinical trial with Yselty®; • Patients participating in an investigational program with interventions outside of routine clinical practice; ; There is no treatement arms, nor comparator group as part of the study
• Comparators:
  N/A
• Outcomes:
  N/A
• Data analysis plan:
  Statistical analyses will be of an exploratory and descriptive nature. All variables will be analysed descriptively with appropriate statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by descriptive statistics (i.e., number of patients, mean, standard deviation, minimum, median, quartiles, and maximum). ; Continuous variables will be summarised by absolute value and changes from baseline per analysis time point, if applicable. Missing data in non-interventional research are informative categories indicating coverage of services.; No imputation of missing information will be applied. ; The number and frequency of patients with missing data will be presented as separate category.