Bayer’s intrauterine system Kyleena prevents pregnancy by continuously releasing a low dose of a synthetic hormone – a progestogen called levonorgestrel.
The system acts locally by thickening the cervical mucus and thinning the endometrium, creating an environment in the uterus that inhibits sperm function and movement.
Regulatory approval came after Phase III clinical trial showed that it “is highly effective and well tolerated regardless of age and parity,” with a 99 percent effectiveness rate and low incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the device from the uterus and uterine perforation, Bayer noted.
“We know that 48 percent of women have missed a pill in the past three months. Missing the pill can lead to unplanned pregnancy. Kyleena provides women with an additional, reliable and reversible contraceptive option and highlights Bayer’s ongoing commitment to empower women with a broad range of birth control options at different stages of their lives,” said Lars Bruening, chief executive of Bayer UK and Ireland, and UK head of pharma.