Mirena for Endometrial Hyperplasia

(SUNFLOWER Trial)

Recruiting at52 trial locations

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bayer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for women who have started their periods and are diagnosed with nonatypical endometrial hyperplasia, a condition where the uterus lining becomes too thick but isn't cancerous. Participants should not be currently receiving treatment for this condition.

Inclusion Criteria

I am a woman diagnosed with NAEH regardless of my age or if I have had children.

I am a woman over 16 years old and have started my periods.

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)

I haven't used long-acting sex-hormone injections in the last 6 months or short-acting ones in the last 6 weeks.

Treatment Details

Interventions

• Medroxyprogesterone acetate (Hormone Therapy)
• Mirena (Hormone Therapy)

Trial Overview The study compares Mirena (BAY865028), an intrauterine device releasing progesterone, to oral progestins taken daily. The goal is to see if Mirena is more effective in treating the thickening of the uterus lining over a period of 6 months.

Participant Groups

Group I: Levonorgestrel (BAY865028, Mirena) Experimental Treatment 1 Intervention

Mirena will be inserted into the participant's uterus by the investigator on Day 1. At visit 4 (after 6 months) or if a participant discontinues her study participation prematurely, the Mirena will be removed by the investigator.

Group II: Oral progestin Active Control 1 Intervention

Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD