Bayer Starts New Phase III Study with Mirena® for the Treatment of Nonatypical Endometrial Hyperplasia
BAYER AG S/ADR (BAYRY)
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Source: Business Wire
Study further expands clinical development program of Bayer’s long-acting reversible intrauterine system Mirena® (levonorgestrel-releasing intrauterine system) 52 mg.Approximately 121 out of every 100,000 women develop nonatypical endometrial hyperplasia (NAEH), a benign form of endometrial thickening, each year.1 Currently, there are no approved medical treatment options for NAEH in the U.S.Mirena is globally available in more than 120 countries, and approved in the U.S. as a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 8 years and is also indicated for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years.2 Mirena is not FDA approved for the treatment of NAEH. WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today the start of its Phase III study SUNFLOWER, an investigational study evaluating the efficacy and safety of 52mg levonorgestrel
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