Study type

Study topic

Disease /health condition
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.