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FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
Date:10/1/2009

ne hematin method. In the study, Mirena (n=79) was compared to an approved first-line hormonal therapy, medroxyprogesterone acetate (n=81), over six menstrual cycles. Successful treatment was defined when two outcomes were met: 1) a proportion of subjects with end-of-study MBL < 80 mL and 2) a greater than or equal to 50% decrease in MBL from baseline to end-of-study. Mirena demonstrated a significantly superior reduction in MBL. Additionally, a greater number of women in the Mirena arm achieved successful treatment vs. those in the medroxyprogesterone acetate arm (85% vs. 22%: respectively, p=<0.001). The study excluded women with organic or systemic conditions that may cause heavy uterine bleeding (except fibroids, with total volume not > 5 mL). The most common reported adverse events for Mirena in the study were uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.

About Mirena

Mirena (levonorgestrel-releasing intrauterine system) is a removable intrauterine contraceptive that delivers small amounts of hormone directly to the uterus. It is among the most efficacious forms of birth control and works for up to five years. Mirena received FDA approval for the prevention of pregnancy in December 2000. It is currently used by approximately two million women in the U.S. and has been used by more than 15 million women worldwide.(3)

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comp
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SOURCE Bayer HealthCare Pharmaceuticals
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