KYLEENA (levonorgestrel), intrauterine device with progestin

High clinical benefit in contraception, though no demonstrated clinical benefit over MIRENA and JAYDESS.

•  KYLEENA has been granted marketing authorisation in contraception, for a maximum period of 5 years.

• During two open-label comparative studies, lasting 3 years, with no statistical analysis:

  - in one study, the observed Pearl index was 0.82 with KYLEENA and 0.00 with MIRENA

  - in the other study, the observed Pearl index was 0.31 with KYLEENA and 0.33 with JAYDESS. For patients included in an extension phase the PEARL index of KYLEENA was 0.29 [0.16; 0.50] over a 5-year contraception period.

• At the end of the 3-year study period, the duration of bleeding per 90-day period was similar between the groups having received KYLEENA, MIRENA and JAYDESS. The proportion of patients with amenorrhoea after 3 years was similar for MIRENA and KYLEENA, and higher for KYLEENA than for JAYDESS.

• As is the case of other intrauterine devices with progestin, this is a second-line contraceptive device, after copper devices.