DARWIN EU® - Impact of risk minimisation measures related to the risk of meningioma in women using nomegestrol and chlormadinone

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CHLORMADINONE

  NOMEGESTROL ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (G03DB04) nomegestrol

  nomegestrol

  (G03DB06) chlormadinone

  chlormadinone
• Medical condition to be studied:
  Meningioma

Population studied

• Short description of the study population:
  The source population will comprise all females aged >10 present in the database at any time during the period from 1st of January 2010 (or start according to the database) to end of data availability. All patients will need to have at least 365 days of data visibility prior to index date. ; For patient-level DUS, the study population will be additionally restricted to new medicine users (see “8.6. Variables” for further details). For objective 2, 4 and 5 these will be restricted to participants newly prescribed with NOMAC or CMA. For objective 3, these will be all drug classes of interest.

Study design details

• Study design:
  Retrospective cohort studies will be conducted using routinely collected health data from 3 databases from 3 countries in Europe.
• Main study objective:
  1. To assess the monthly prevalence and incidence of use of drug classes of interest before and after the implementation of the restrictions of use. ; 2. To assess duration of use and cumulative dose of products containing NOMAC or CMA before and after the implementation of restrictions of use. ; 3. To describe characteristics of users of relevant drug classes before and after implementation of the restrictions of use. ; 4. To describe the line of treatment (2nd/3rd versus 1st) in users of products containing NOMAC or CMA before and after the implementation of the restrictions of use. ; 5. To describe the frequency of patients who develop meningioma during treatment with products containing NOMAC or CMA, and those who discontinue or switch to alternative treatments before and after implementation of the restrictions of use. ; 6. To assess the impact of the restrictions of use adopted in 2018 and 2022 in incident prescriptions of products containing NOMAC or CMA.;
• Setting:
  This study will be conducted using routinely collected data from 3 databases in 3 European countries selected from the DARWIN EU® Database Catalogue.