A Study to Learn How Well Mirena Works as Compared to Oral Progestin in Nonatypical Endometrial Hyperplasia in Women Who Have Started Their Periods (SUNFLOWER)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Post-menarchal women (≥ 16-years) at the time of signing the informed consent.
- Women with histologically confirmed NAEH independent of their parity or menopausal status.
Exclusion criteria
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
- Congenital or acquired uterine or cervical anomaly including fibroids, or cervical stenosis that in the opinion of the investigator, would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
- Use of any long-acting injectable sex-hormone preparations within 6 months prior to the start of study intervention, and /or short acting hormonal medication within 6 weeks prior to the start of study intervention.
- Pregnancy
- Participants with either known family or personal history of genetic predisposition to uterine, ovarian or colorectal cancers (e.g. Lynch syndrome).
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Bayer Clinical Trials Contact
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal