Pharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden (Jaydess DUS)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEVONORGESTREL
• Anatomical Therapeutic Chemical (ATC) code:
  (G03AC03) levonorgestrel

Population studied

• Short description of the study population:
  The study population involved female patients, first time users of levonorgestrel contraceptive intrauterine system (JAYDESS), identified through Swedish national health registers (Prescribed Drug Register, the Patient Register and the Medical Birth Register) and the population register.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Study duration of use and indication for use of JAYDESS
• Outcomes:
  - Duration of use of JAYDESS - Indication for use, - Age at insertion and removal
• Data analysis plan:
  Simple descriptive statistics presenting means and proportions

Documents

Study results

16903_EU PAS Abstract_V1.0_2022-08-22

Study report

16903_Study Report_Redacted_V1.0_2022-08-22