Patterns and Determinants of Use of Oral Contraceptives in the European Union (Use of OC in the EU)

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

  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G03AA) Progestogens and estrogens, fixed combinations

  Progestogens and estrogens, fixed combinations

  (G03AB) Progestogens and estrogens, sequential preparations

  Progestogens and estrogens, sequential preparations

  (G03AC) Progestogens

  Progestogens

Population studied

• Short description of the study population:
  All women in the database any time in 2009 or 2010, and who have at least one year follow-up in the database.; All women with a prescription (IPCI, THIN) or dispensing (PHARMO, SISR-T, SISR-L) of oral contraceptives during study follow-up were selected as users.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1500000

Study design details

• Main study objective:
  Specific study objectives are to assess among women using oral contraceptive in 2009 and 2010 in different countries in Europe:- prevalence estimates (users on January 1, 2010)- incidence estimates (new users per year)- demographics- health indicators and morbidity- treatment characteristics
• Data analysis plan:
  Descriptive statistics will include proportions, mean and standard deviations (sd), median and interquartile ranges (IQR) of the aggregated datasets. Incidence and prevalence will be presented for the pooled dataset as well as for the individual datasets. Population and treatment characteristics will be presented for the individual datasets. Stratified analysis will be performed per database and separately for incident and prevalent users. In addition, analysis will be performed by age category and presented in strata if needed.

Documents

Study results

EMA OC. Del 2.b_Final

Study, other information

Note on data collection timelines