Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• 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:
  LEVONORGESTREL
• Medical condition to be studied:
  Anxiety

  Panic attack

  Sleep disorder

  Restlessness

Population studied

• Short description of the study population:
  Control group consists of women using IUDs not medicated with levonorgestrel (or other hormonal product).; Active arm of the study included women fitted with an levonorgestrel-releasing intrauterine devices and with more than one year of prior data collection in THIN.
• Age groups:
  Adults (18 to < 46 years)

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

Study design details

• Main study objective:
  Exposure to a levonorgestrel-releasing intrauterine device has been associated with depression and, more recently, a connection to anxiety, panic attacks, sleep problems and restlessness has been suggested. This study uses data from the THIN database of UK general practice to investigate these suggestions.
• Outcomes:
  First occurrence of Read codes for anxiety, panic attacks, sleep problems and restlessness. For anxiety and sleep problems appropriate prescriptions of relevant treatments were also considered to indicate the condition. An analysis of depression as a positive control was included.
• Data analysis plan:
  Hazard ratios for the first occurrence of psychiatric symptoms or prescriptions of disease-specific treatments will be calculated on an intention-to-treat basis using a proportional hazards model.