|
Bayer, a global leader in women’s healthcare, announced the clinical phase III study SUNFLOWER (Study ofUnderstandingNAEH - treatmenteFficacy ofLevonOrgestrel – IUS inWomenElectingnon-suRgical options) with its 52mg levonorgestrel-releasing intrauterine system (LNG-IUS) Mirena. The study will investigate the efficacy and safety of the 52mg LNG-IUS in the treatment of nonatypical endometrial hyperplasia (NAEH) in women.
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.
The phase III clinical study SUNFLOWER (Study ofUnderstandingNAEH - treatmenteFficacy ofLevonOrgestrel – IUS inWomenElectingnon-suRgical options) will evaluate the treatment of nonatypical endometrial hyperplasia (NAEH) with 52mg LNG IUS versus Oral Progestin (OP) and aims to enroll 207 patients at about 90 centers in 3 countries. The study is anticipated to take around 1.5 years until completion. Previous studies that have tested the use of 52mg LNG-IUS for the treatment of this condition indicate good response based on the type of hormone present in the IUS and the direct effect inside the uterus, helping to bring the endometrium back to normal state in most cases. The aim of SUNFLOWER is to assess how 52mg LNG-IUS is treating NAEH in a controlled clinical study.
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.
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.
|