"Bayer announced today that the U.S. Food and Drug Administration FDA approved Kyleena levonorgestrelreleasing intrauterine system . mg a progestincontaining intrauterine system IUS for the prevention of pregnancy for up to five years. Kyleena will be available by prescription only in October .   Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture.  Data show that the use of effective longacting birth control methods including intrauterine devices  or IUDs  have helped to reduce unintended pregnancies in the United States but we still have a long way to go  said Anita L. Nelson M.D. Professor and Chair Obstetrics and Gynecology at Western University of Health Sciences Pomona Calif. Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a lowdose nondaily birth control method. Kyleena is a small flexible plastic Tshaped device containing . mg of a progestin hormone called levonorgestrel. Kyleena is placed by a healthcare provider during an inoffice visit and prevents pregnancy for up to five years but may be removed by a healthcare provider at any time. With the approval of Kyleena women have an important new birth control option that provides pregnancy prevention for up to five years said Dario Mirski M.D. Senior Vice President and Head of Medical Affairs for the Americas Bayer. Kyleena expands Bayers IUD portfolio and is part of our commitment to provide women and their healthcare providers with a variety of contraceptive choices to meet their individual needs. The use of longacting reversible contraception LARCs has increased nearly fivefold in the last decade. Because Kyleena slowly releases levonorgestrel into a womans uterus only small amounts of the hormone enter the blood. For the first  to  months a womans period may become irregular and the number of bleeding days may increase. Women may also have frequent spotting or light bleeding. Some women have heavy bleeding during this time. After using Kyleena for a while the number of bleeding and spotting days is likely to lessen. For some women periods will stop altogether. When Kyleena is removed menstrual periods should return. About the Clinical Trial for Kyleena The contraceptive efficacy of Kyleena was evaluated in a clinical trial that enrolled generally healthy women aged  to  of whom  received Kyleena. Of these   were nulliparous women   women completed  years of the study   elected to enroll in an extension phase up to a total of  years and   completed  years of use. The trial was a multicenter multinational randomized openlabel study conducted in  countries in Europe Latin America the U.S. and Canada. Women less than six weeks postpartum with a history of ectopic pregnancy with clinically significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded. A total of   were treated at U.S. sites and   were at nonU.S. sites. The racial demographics of enrolled women who received Kyleena was Caucasian  BlackAfrican American . Other . and Asian .  indicated Hispanic ethnicity. The clinical trial had no upper or lower weight or BMI limit. The weight range was  to  kg mean weight . kg and mean BMI was . kgm range .. kgm. Of Kyleenatreated women  discontinued the study treatment due to an adverse reaction . were lost to followup . withdrew for unspecified reasons . discontinued due to a protocol deviation . discontinued due to pregnancy and  discontinued due to other reasons. The pregnancy rate calculated as the Pearl Index PI in women aged  years was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on day equivalent exposure cycles evaluable cycles excluded those in which backup contraception was used unless a pregnancy occurred in that cycle. The Year  PI was based on  pregnancies and the cumulative year pregnancy rate was based on  pregnancies that occurred after the onset of treatment and within  days after Kyleena removal or expulsion. Kyleena Clinical Trial Pearl Index Cumulative Year  Kaplan Meier Rate   Year  Year  Year  Year  Year    Number of Evaluable day Cycles of Exposure        Pregnancy Rate  Confidence Interval . . . . . . . .. . . . . . . . . .  About  of  women who desired pregnancy after study discontinuation and provided followup information conceived within  months after removal of Kyleena. The most common adverse reactions occurring in   users were vulvovaginitis  ovarian cyst  abdominal painpelvic pain  headachemigraine  acneseborrhea  dysmenorrheauterine spasm  breast painbreast discomfort  and increased bleeding . In the combined studies  discontinued prematurely due to an adverse reaction. The most common adverse reactions   leading to discontinuation were increased bleeding . abdominal painpelvic pain . device expulsion . acneseborrhea . and dysmenorrheauterine spasm .. In the clinical trials serious adverse reactions occurring in more than a single subject included ectopic pregnancyruptured ectopic pregnancy  subjects pelvic inflammatory disease  subjects missed abortionincomplete spontaneous abortionspontaneous abortion  subjects ovarian cyst  subjects abdominal pain  subjects depressionaffective disorder  subjects and uterine perforationembedded device myometrial perforation  subjects. Indication for Kyleena  Kyleena levonorgestrelreleasing intrauterine system is a hormonereleasing IUD that prevents pregnancy for up to  years. Important Safety Information for Kyleena   If you have a pelvic infection get infections easily or have certain cancers dont use Kyleena. Less than  of users get a serious pelvic infection called PID.   If you have persistent pelvic or stomach pain or if Kyleena comes out tell your doctor. If Kyleena comes out use backup birth control. Kyleena may attach to or go through the uterus and cause other problems.   Pregnancy while using Kyleena is uncommon but can be life threatening and may result in loss of pregnancy or fertility.   Ovarian cysts may occur but usually disappear.   Bleeding and spotting may increase in the first  to  months and remain irregular. Periods over time usually become shorter lighter or may stop. Kyleena does not protect against HIV or STDs. Only you and your healthcare provider can decide if Kyleena is right for you.  Kyleena is available by prescription only. For important risk and use information about Kyleena please see the Full Prescribing Information httplabeling.bayerhealthcare.comhtmlproductspiKyleena_PI.pdf Bayer Science For A Better Life Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time the Group aims to create value through innovation growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal  the Group employed around  people and had sales of EUR . billion. Capital expenditures amounted to EUR . billion RD expenses to EUR . billion. These figures include those for the hightech polymers business which was floated on the stock market as an independent company named Covestro on October  . For more information go to  http   Bayer  Bayer and the Bayer Cross are registered trademarks of Bayer. Kyleena is a trademark of Bayer. ForwardLooking Statement This news release may contain forwardlooking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks uncertainties and other factors could lead to material differences between the actual future results financial situation development or performance of the company and the estimates given here. These factors include those discussed in Bayers public reports which are available on the Bayer website at  http The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments.  Kyleena Prescribing Information September .  Finer LB and Zolna MR Declines in unintended pregnancy in the United States  New England Journal of Medicine   httpnejm.orgdoifull.NEJMsa.  Branum AM Jones J. Trends in longacting reversible contraception use among U.S. women aged . NCHS data brief no . Hyattsville MD National Center for Health Statistics. . Photo  httpphotos.prnewswire.comprnh Logo  httpphotos.prnewswire.comprnhNYLOGO SOURCE Bayer Related Links http"