EURAS-LCS12_V01
Research type
Research Study
Full title
European Active Surveillance Study of LCS12
IRAS ID
279792
Contact name
Klaas Heinemann
Contact email
Sponsor organisation
ZEG Berlin GmbH
Clinicaltrials.gov Identifier
6476, EU PAS Register Number; NCT02146950, ClinicalTrial.gov Identifier
Duration of Study in the UK
12 years, 0 months, 13 days
Research summary
Copper-containing intrauterine devices (IUDs) and levonorgestrel-releasing (hormonal) IUDs are methods of birth control which are fitted into a woman's womb. IUDs are highly effective at preventing pregnancy. Regardless of IUD type, there are some potential but uncommon unwanted effects of IUDs. These include pregnancy if the IUD fails to work, infection (pelvic inflammatory disease, usually in the few weeks after IUD fitting) and uterine perforation.
Jaydess and Kyleena are new hormonal IUDs which were introduced to the European market in 2014 and 2016. Although research has shown both Jaydess and Kyleena are highly effective and well-tolerated, there is no research between Jaydess, Kyleena and other established IUDs in routine clinical practice.
This study is to find out whether there are differences in failure (pregnancy) rates between Jaydess, Kyleena and other IUDs. In addition, uncommon or serious adverse events like pelvic inflammatory disease, uterine perforation and ectopic pregnancies will be studied.
Women who have had an IUD fitted will be asked by their healthcare professional (HCP, e.g. specialist nurse, general practitioner) if they are interested in study participation. If a woman consents to take part in the study, she and her HCP complete a questionnaire on the IUD fitted, basic socio-demographic data and medical and gynecological history. Participants will receive up to 7 follow-up questionnaires over 3-5 years. All participant reported outcomes of interest will be validated with the HCP.
The needed number of enrolled women and total time of observation was calculated in such a way that a valid statistical assessment can conclude whether contraceptive failure in Jaydess and Kyleena users is not (unacceptably) worse than other IUD users.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0148
Date of REC Opinion
3 Aug 2020
REC opinion
Further Information Favourable Opinion