European Active Surveillance Study of LCS12 (EURAS-LCS12)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45939
• EU PAS number:
  EUPAS6476
• Study ID:
  45939
• Official title and acronym:
  European Active Surveillance Study of LCS12 (EURAS-LCS12)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Finland

  France

  Germany

  Italy

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  Intrauterine systems (IUS) have a high contraceptive efficacy. LCS12 is a new IUS which contains levonorgestrel. Because there is a lack of comparative data between LCS12 and Mirena (and copper IUDs), it remains unclear whether there are differences in contraceptive failure rates between LCS12 and either Mirena or copper IUDs. In addition, any transcervical procedure is potentially associated with the risk of infection/inflammation. The primary objective is to determine whether LCS12 is associated with a higher risk of unintended pregnancy compared to Mirena and compared to copper IUDs. Secondary objectives are the investigation of pelvic inflammatory disease (PID), uterine perforations and ectopic pregnancies. The study also aims to capture the drug utilization pattern of LCS12 and established IUDs during routine clinical practice, outcomes of unintended pregnancies, risk of serious adverse events, difficulties associated with IUD insertion, cervical conization procedures, and neuropsychiatric disorders/disturbances (since 2017). In the course of the study, another hormonal IUD ( 'Kyleena') was launched which has the same dimensions as LCS12, but a higher LNG content, and is approved for use up to 5 years. The initial LNG release rates are approximately 14 µg/24h for LCS12, 20 µg/24h for Mirena and 17.5 µg/24h for Kyleena. New users of Kyleena were continuously enrolled in the study since the market introduction and are categorized as 'other hormonal IUD'. However, with increasing usage of Kyleena and enrolment into the EURAS-LCS12 study, the SMAC endorsed inclusion of Kyleena as an official cohort to the study to better understand current routine clinical practice. As comparative data on contraceptive failure between Kyleena and Mirena based on routine clinical practice are not available at present, the comparison of contraceptive failure rates between Kyleena and Mirena / copper IUDs was added as an additional secondary outcome to the EURAS-LCS12 study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Berlin Center for Epidemiology & Health Research, ZEG Berlin

Germany

Study timelines

Date when funding contract was signed

Actual: 18/12/2013

Study start date

Planned: 01/06/2014

Actual: 02/06/2014

Date of final study report

Planned: 30/09/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

EURAS-LCS12_Protocol_FINAL_2014_02_21

Updated protocol

LCS12_StudyProtocol_V04.00_Amend 5_V02-00_20211105-clean

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)

Other study registration identification numbers and links

https://clinicaltrials.gov/ct2/show/NCT02146950