You are being asked to take part in this study because you have endometrial hyperplasia (a
pre-cancerous growth of the lining of the uterus) and/or early-stage endometrial cancer.
The goal of this clinical research study is to learn if the Mirena intrauterine device
(levonorgestrel IUD), alone or in combination with everolimus, is effective for the treatment
of endometrial hyperplasia and/or early-stage endometrial cancer.
This is an investigational study. The levonorgestrel IUD is commercially available and FDA
approved as a form of birth control. The use of the IUD itself to treat endometrial cancer is
investigational. Everolimus is FDA approved and commercially available to treat kidney,
breast, and pancreatic cancers. The combination of everolimus and the levonorgestrel IUD in
this study to treat endometrial cancer is investigational.
Up to 270 patients will be enrolled in this study. Up to 250 will take part at MD Anderson
and up to 20 will take part at the Harris Health System.