Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH).
Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer.
Currently, oral progestins (OP) which are progesterone (female hormone) capsules taken by mouth, are used to treat NAEH. However, there is still a need for other treatments due to unmet needs.
The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone.
In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body.
The main purpose of this study is to learn how well Mirena works compared to oral in NAEH in women who have started their periods.
For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral progestins.
The study participants will be randomly divided equally into one of two treatment groups. Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months.
Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site.
Participants will visit the study clinic:
- once before the treatment starts
- 3 times with a gap of 3 months between the visits during the treatment
- then 1 more time after the treatment ends
During the study, the doctors and their study team will:
- check participant's health by performing tests such as blood and urine tests
- perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time.
- take samples of womb (endometrial) lining
- ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Post-menarchal Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Progestin for 6 Months
