Levosert PASS 010-100

• Research type

  Research Study

• Full title

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

• IRAS ID

  217931

• Contact name

  Paula Briggs

• Contact email

  paula.briggs@nhs.net

• Sponsor organisation

  Gedeon Richter Plc.

• Clinicaltrials.gov Identifier

  EUPAS7857, Levosert

• Duration of Study in the UK

  2 years, 7 months, 24 days

• Research summary

  The study is a non interventional, multi-centre, uncontrolled, voluntary, PASS (category 3)study.
  The primary objective of this PASS is to characterise the ease of
  insertion and the safety profile of Levonorgestrel IUS during insertion, under routine clinical practice.
  The secondary objective of the study is to characterise the utilisation pattern for Levonorgestrel IUS in
  a real-world setting. The study will include women in whom Levonorgestrel IUS is inserted for any indication
  as part of routine care.
  Inclusion criteria:
   Willing and able to provide written informed consent
   Prescribed Levonorgestrel IUS as part of routine clinical care prior to enrolment.
  Exclusion criteria: there is no exclusion criteria for the study

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  17/LO/1318

• Date of REC Opinion

  18 Aug 2017

• REC opinion

  Further Information Favourable Opinion