Active post-marketing surveillance of Levonorgestrel IUS insertion related difficulties: a non-interventional post-authorisation safety study

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multinational, multi-centre, PASS study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LEVONORGESTREL
• Medical condition to be studied:
  Abnormal uterine bleeding

Population studied

• Short description of the study population:
  The study focused on women who had prescribed with levonorgestrel intrauterine system (IUS) for any indication as a part of routine care. ; Inclusion criteria:; 1. Willing and able to provide written informed consent; 2. Prescribed levonorgestrel IUS as part of routine clinical care prior to enrolment.; ; Exclusion criteria:; 1. There are no exclusion criteria for this study.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The primary objective of this PASS is to characterize, under routine practice, the ease of insertion and the safety profile of Levonorgestrel IUS during insertion in a study population that is representative of the actual users of the IUS (either new users and patients switching from Mirena).
• Outcomes:
  IUS insertion related adverse events, The indication of use of levonorgestrel IUS
• Data analysis plan:
  DCF information will be entered in the Clinical and, partially, in the Pharmacovigilance databases. Details of treatment initiation and prescribing reasons as reported on the questionnaire will be provided using descriptive statistics. Prescribing pattern will be assessed. The reported insertion problems will be provided in a listing which will also be part of the Final Clinical Study Report. General comments about the readability of the instructions for use and handling will be recorded for potential future improvements.