Bayer begins phase III study with long-acting reversible intrauterine system for treatment of nonatypical endometrial hyperplasia

Bayer has officially announced the clinical Phase III study SUNFLOWER with its 52mg levonorgestrel-releasing intrauterine system Mirena. The study will investigate the efficacy and safety of the 52mg LNG-IUS in the treatment of nonatypical endometrial hyperplasia in women.

Note that Nonatypical endometrial hyperplasia (NAEH) is an abnormal thickening of the lining of the uterus, known as endometrium, due to an imbalance between estrogen and progesterone levels. This condition is classified as nonatypical as the cells in the endometrium do not show signs of cancer. It can be silent, or present with heavy or abnormal bleeding, or bleeding after menopause. If untreated, this condition may lead to uterine cancer.

“Having a leading position in global women’s health we are committed to advance science focusing on innovative options to address the unmet medical need of women globally. With this new Phase III study, we are now expanding our broad clinical development program for intrauterine systems to be able to support women suffering from nonatypical endometrial hyperplasia with an effective treatment”, said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division.

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Bayer, naeh, nonatypical endometrial hyperplasia