Bayer begins Phase III study with Mirena for nonatypical endometrial hyperplasia

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. The annual incidence of nonatypical endometrial hyperplasia (NAEH) ranges from 121 to 270 per 100.000 women depending on the geography, age and menopause status. Currently, there are no approved medical treatment options for this condition presenting a high unmet medical need given its potential to progress to an atypical form or even 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.

Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus. Mirena is a long-acting reversible contraceptive (LARC) and can be removed at any time by a healthcare provider if a woman’s plans change. The current approved indications which may vary from country to country are contraception (prevention of pregnancy), idiopathic menorrhagia/ heavy menstrual bleeding (HMB), endometrial protection during estrogen therapy for menopause and dysmenorrhea (painful periods). Mirena is available in more than 120 countries.