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

Study identification

• EU PAS number:
  EUPAS7857
• Study ID:
  26348
• Official title and acronym:
  Active post-marketing surveillance of Levonorgestrel IUS insertion related difficulties: a non-interventional post-authorisation safety study
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Czechia

  Denmark

  Hungary

  Lithuania

  Norway

  Poland

  United Kingdom
• Study description:
  The PASS STUDY is an observational study with primary objective 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 user and patients switching from Mirena). And with secondary objective to characterize the utilization pattern for Levonorgestrel IUS. The Data Clarification Form (DCF) will be included in the Levonorgestrel IUS package. The doctors will be asked to complete and send it to the sponsor on spontaneous basis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gedeon Richter

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/10/2014

Actual: 15/10/2014

Study start date

Planned: 16/10/2014

Actual: 16/10/2014

Date of final study report

Planned: 21/12/2020

Actual: 28/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter Plc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)