NCT06904274 · Bayer
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)
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Participants with either known family or personal history of genetic predisposition to uterine, ovarian or colorectal cancers (e.g. Lynch syndrome).
Where
- Birmingham, Alabama
- Mobile, Alabama
- Glendale, Arizona
- Mesa, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Burbank, California
- Gardena, California
- Inglewood, California
- Sacramento, California
- San Diego, California
- West Hills, California
And 50 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations