Study identification

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

Contact details

Klaas Heinemann

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
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)