Bayer has announced the initiation of the Phase III SUNFLOWER study, designed to assess the safety and effectiveness of the 52mg levonorgestrel-releasing intrauterine system Mirena for treating nonatypical endometrial hyperplasia in women. Nonatypical endometrial hyperplasia is a condition where the lining of the uterus becomes abnormally thick due to an imbalance of estrogen and progesterone. The cells in this condition do not show cancerous changes, but women may experience heavy, irregular, or postmenopausal bleeding, and if left untreated, the condition can increase the risk of uterine cancer. Approximately 121 women per 100,000 develop NAEH each year, and currently, there are no approved medical treatments available, creating a significant unmet need.
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George L. Maxwell, MD, Principal Investigator of the SUNFLOWER study, emphasized the potential benefits of intrauterine levonorgestrel, stating that prior studies suggest it may help restore the endometrium to a normal state. He explained that this study represents a critical step in exploring the therapeutic potential of Mirena beyond its established roles in pregnancy prevention and management of heavy menstrual bleeding.
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The SUNFLOWER study is a Phase III, multicenter trial comparing Mirena to an oral progestin. It aims to enroll 207 participants across approximately 90 sites in three countries, with an expected duration of 18 months.
Mirena is a hormone-releasing intrauterine device that provides up to eight years of pregnancy prevention and can manage heavy menstrual bleeding for up to five years for women choosing intrauterine contraception.
Important safety considerations include avoiding Mirena if you have certain pelvic infections, are prone to infections, or have specific cancers. Serious pelvic infection occurs in fewer than 1% of users. Patients should inform their healthcare provider about persistent pain, unusual bleeding, or if the device dislodges. Pregnancy while using Mirena is rare but can be life-threatening. Other potential effects include ovarian cysts, changes in bleeding patterns, and irregular spotting initially. Mirena does not provide protection against HIV or sexually transmitted infections.
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