LEVERKUSEN (dpa-AFX) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L) announced it has submitted an application for marketing authorization in both the European Union and in the United States for LCS-16, an intrauterine system, which is directly placed in the uterus for contraception for up to five years.
LCS-16 is a small, flexible plastic T-shaped device. Once placed in the uterus, it releases a low dose of the progestogen levonorgestrel directly into the uterus and provides effective birth control for up to five years. It also offers rapid return to a woman's usual level of fertility after removal.
Bayer said the data from Phase III clinical trials have demonstrated that LCS-16 is highly effective and well tolerated, and was more than 98.5 percent effective in preventing pregnancy. Low incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the device from the uterus and uterine perforation were seen.
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