Study Stopped
Bayer cancelled study 22923 due to enrollment challenges, including difficulties identifying eligible patients, participation requirements, and site burden. The decision was unrelated to safety and does not change Mirena's benefit-risk profile.
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
SUNFLOWER
A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Medroxyprogesterone Acetate for 6 Months
1 other identifier
interventional
N/A
3 countries
38
Brief Summary
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, there are no approved treatments for NAEH and that is why there is still an unmet medical need. 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 show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2025
Shorter than P25 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2026
CompletedJuly 30, 2026
July 22, 2026
7 months
March 21, 2025
July 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with Complete Resolution (CR) of NAEH
Complete Resolution will be evaluated as benign endometrium.
At 6 months
Secondary Outcomes (5)
Recurrence of NAEH after CR
At 3 months follow up after 6 months treatment
Progression after CR
At 3 months follow up after 6 months treatment
Proportion of participants having hysterectomy
During treatment and 3 months follow up
Diagnosis of "benign endometrium"
At 6 months of treatment followed by 3 month treatment-free follow up
Number of participants with adverse events
From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention
Study Arms (2)
Levonorgestrel (BAY865028, Mirena)
EXPERIMENTALMirena 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.
Oral progestin
ACTIVE COMPARATORParticipants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).
Interventions
Eligibility Criteria
You may qualify if:
- Post-menarchal women (≥18 years) at the time of signing the informed consent.
- Women with histologically confirmed NAEH independent of their parity or menopausal status. Endometrial samples will be obtained either at screening or no more than 42 days prior to the signing of the informed consent form.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (38)
Velocity Clinical Research - Phoenix
Phoenix, Arizona, 85006, United States
Cornerstone Clinic for Women - Aldersgate
Little Rock, Arkansas, 72205, United States
Alliance Clinical West Hills
West Hills, California, 91307, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, 33016, United States
New Age Medical Research Corp.
Miami, Florida, 33186, United States
Entrust Clinical Research
Palmetto Bay, Florida, 33176, United States
Emerald Coast Clinical Research
Panama City, Florida, 32405, United States
Paramount Research Solutions | College Park Location
Atlanta, Georgia, 30327, United States
Office of Dr. Cindy Basinski, LLC
Evansville, Indiana, 47715, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118, United States
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, 48127, United States
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109, United States
Unified Women's Clinical Research - Centre OB/GYN
Raleigh, North Carolina, 27607, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, 43213, United States
OB/GYN Associates of Erie
Erie, Pennsylvania, 16507, United States
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, 37412, United States
Discovery Clinical Trials - Dallas
Dallas, Texas, 75230, United States
Biopharma Informatic - West Houston
Houston, Texas, 77043, United States
AIH Research- Broadway
Pearland, Texas, 77584, United States
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, K1H 7W9, Canada
Mount Sinai Hospital Toronto | Gynecology
Toronto, Ontario, M5G 1Z5, Canada
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking Union Medical College Hospital CAMS
Beijing, Beijing Municipality, 100730, China
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, 401147, China
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, 361003, China
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, Guangdong, 510630, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Tangshan Maternal and Child Health Care Hospital
Tangshan, Hebei, 063014, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, Jiangsu, 210011, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Women and Children's Hospital, Qingdao University - Gynecology department
Qingdao, Shandong, 266034, China
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, 610091, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2025
First Posted
April 1, 2025
Study Start
November 24, 2025
Primary Completion
June 17, 2026
Study Completion
June 17, 2026
Last Updated
July 30, 2026
Record last verified: 2026-07-22
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.