quot; Many women with heavy periods often suffer in private with their symptoms. And because no effective approved surgical treatment options are limited, women who seek treatment for heavy periods are often faced with the option of having surgical procedures, such as histerectom�aquot, said Dr. Andrew Kaunitz, MD, Associate Professor and Head, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville. quot; In a clinical trial, almost nine out of 10 women were successfully treated for heavy menstrual bleeding with Mirena meaning it reduces the monthly blood loss by over 50 percent from the baseline and below 80 ml. This makes it effective, nonsurgical first line option quot;. br quot; Mirena has a proven track record as an effective contraceptive that lasts up to five years. We are excited now, Mirena also offers as a treatment option for women with heavy menstrual bleeding who want to use an intrauterine device for anticoncepci�nquot, said Stefan Oelrich, Vice President and General Manager, Women # 39; s Health Care, Bayer HealthCare Pharmaceuticals . quot; Today's announcement demonstrates our continued effort to improve the health of mujer.quot; br only a woman and her doctor can determine whether Mirena is right for her. Mirena is recommended for women who have had a child. Mirena should not be used by a woman who has a pelvic infection, infections easily give or have certain types of cancer. Less than 1% of users of contracting a serious infection called pelvic inflammatory disease. A woman should consult your health care provider about the problems associated with this condition. Mirena may accompany or go through the wall of the uterus and cause other problems. If Mirena out, a woman must use another form of birth control and call your healthcare provider. In the rare event in a woman becomes pregnant while using Mirena, seek emergency medical care for pregnancy with an IUD can cause pregnancy loss or loss of fertility. Pelvic and / or abdominal pain. If persistent, women should talk with their healthcare provider. Ovarian cysts may occur and typically disappear. Bleeding and spotting may be increased in the early months and remains patchy. Periods may be shorter, lighter or even stop. Mirena does not protect against HIV or sexually transmitted diseases. br FDA approval is based on data from a randomized, open, active control, parallel group trial of 160 healthy women of reproductive age who had confirmed the heavy menstrual bleeding and had no known medical condition because of the menorrhagia, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of greater than or equal to 80 ml, was determined using the alkaline haematin method. In the study, Mirena (n = 79) was compared with the approved firstline treatment, hormonal, medroxyprogesterone acetate (n = 81), over six menstrual cycles. Treatment success was defined when two outcomes are met: 1) a proportion of subjects with endof MBL study 5 ml). The most common adverse events reported in the study were Mirena uterine bleeding or spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness. br Mirena (levonorgestrelreleasing intrauterine system) is a removable intrauterine contraceptive that provides small amounts of the hormone directly into the uterus. It is one of the most effective forms of birth control and works up to five years. Mirena received FDA approval for prevention of pregnancy in December 2000. It is now used by about two million women in the U.S. and has been used by more than 15 million women worldwide (3). br Bayer HealthCare Pharmaceuticals Inc. is the company based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the health and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Neurology and Hematology / Oncology. The company's objective is to discover and manufacture products that improve human health worldwide by diagnosing, preventing and treating disease. br This press release may contain forwardlooking statements based on current assumptions and forecasts of the Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between actual results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forwardlooking statements or adapt them to future events or developments. br br
