Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(G03F) PROGESTOGENS AND ESTROGENS IN COMBINATION
Population studied

Short description of the study population

For the Dutch drug utilization study and cohort study: All women between the ages of 18-49 years with at least one prescription of combined oral contraceptive use in the period from January 2012 through December 2015 will be included, i.e., both new users as well as prevalent users.
For the Danish drug utilization and cohort study: Women between the ages 18-49 years in the period January 2012- December 2015 will be included, i.e. both new and prevalent users.
For the UK drug utilization and cohort study: women between the ages 18-49 years who have been registered for at least two years prior with one of the general practices that contributed data to The Health Improvement Network (THIN) primary care database will be included.

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Women of childbearing potential not using contraception
Women of childbearing potential using contraception

Estimated number of subjects

500000
Study design details

Main study objective

1. To investigate trends in new user (initiators) prescribing patterns in the two years preceding the relevant Commission Decision 2. To investigate switching patterns between products among prevalent users3. To examine changes in users' clinical characteristics4. To examine differences in VTE einidence rates

Data analysis plan

For each calendar year, we provide - estimates of the number and proportion of new users of each oral contraceptive type and the number and proportion of switchers (from one type to another or to a different dose) - estimates of the proportion of each oral contraceptive type and the number of switchers (from one type to another or to a different pill strength) December 2015), we will perform segmented regression analysis.- number of initiators of each oral contraceptive type and the number of switchers (from one type to another or to a different dose) overall and stratified by age at initiation of CHC, social deprivation, body mass index (BMI) and smoking status. We will tabulate the estimates of the annual incidence of VTE including 95% confidence intervals for each calender window of the study period.
Documents
Study publications
Khialani D, Jones ME, Szépligeti SK, Ording AG, Ehrenstein V, Petersen I, van H…