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
207
3 countries
86
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
participants targeted
Target at P25-P50 for phase_3
Started Nov 2025
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
August 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2027
April 30, 2026
April 1, 2026
1.7 years
March 21, 2025
April 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 (86)
UAB Medicine Center for Research in Women's Health
Birmingham, Alabama, 35233, United States
Women's Health Alliance of Mobile
Mobile, Alabama, 36604, United States
AMR - Mobile, AL
Mobile, Alabama, 36608, United States
Velocity Clinical Research - Mobile
Mobile, Alabama, 36608, United States
North Valley Women's Care
Glendale, Arizona, 85308, United States
Mesa Obstetricians and Gynecologists | Research Department
Mesa, Arizona, 85206, United States
Marchand OB/GYN
Mesa, Arizona, 85209, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, 85006, United States
Cornerstone Clinic for Women - Aldersgate
Little Rock, Arkansas, 72205, United States
Velvet Clinical Research
Burbank, California, 91506, United States
Allen Clinical Research LLC
Gardena, California, 90247, United States
UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN
Sacramento, California, 95817, United States
Alliance Clinical West Hills
West Hills, California, 91307, United States
OB/GYN Department_Comprehensive Women's Health Center
Denver, Colorado, 80230, United States
AMR - Fort Myers, FL
Fort Myers, Florida, 33912, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, 33016, United States
UF Health Women's Specialists - Emerson
Jacksonville, Florida, 32207, United States
New Age Medical Research Corp.
Miami, Florida, 33186, United States
K2 Medical Research - South Orlando
Orlando, Florida, 32751, United States
Entrust Clinical Research
Palmetto Bay, Florida, 33176, United States
Emerald Coast Clinical Research
Panama City, Florida, 32405, United States
Physician Care Clinical Research LLC | Sarasota, FL
Sarasota, Florida, 34239, United States
USF Health South Tampa Center for Advanced Healthcare - Gynecology
Tampa, Florida, 33606, United States
Paramount Research Solutions | College Park Location
Atlanta, Georgia, 30327, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Women's Wellness / SKYCRNG
Chicago, Illinois, 60644, United States
Office of Dr. Cindy Basinski, LLC
Evansville, Indiana, 47715, United States
McFarland Clinic - Medical Arts Building - OBGYN
Ames, Iowa, 50010, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Gynecologic Oncology Associates
Shreveport, Louisiana, 71103, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118, United States
The Levi Watkins Jr. MD Outpatient Center - Obstetrics and Gynecology
Baltimore, Maryland, 21287, United States
Tufts Medical Center - OB/GYN
Boston, Massachusetts, 02111, United States
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, 48127, United States
Hutzel Women's Hospital
Detroit, Michigan, 48201, United States
St. Dominic's Gynecology/Oncology
Jackson, Mississippi, 39216, United States
SKY integrative Medical Center
Ridgeland, Mississippi, 39157, United States
McGill Family Practice
Papillion, Nebraska, 68046, United States
Affiliated Clinical Research, Inc. | Las Vegas, NV
Las Vegas, Nevada, 89113, United States
Elite Clinical Network (ECN) | Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030, United States
Rutgers Robert Wood Johnson Medical School - OBGYN
New Brunswick, New Jersey, 08901, United States
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109, United States
Columbia University Medical Center - Gynecology
New York, New York, 10032, United States
Montefiore Medical Park - Eastchester - OBGYN
The Bronx, New York, 10461, United States
Reply OBGYN and Fertility PLLC
Durham, North Carolina, 27713, 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
TriHealth Women's Servies - Seven Hills Women's Health Center
Cincinnati, Ohio, 45255, United States
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, 43213, United States
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
Mayfield Heights, Ohio, 44124, United States
Bethesda North Hospital - Gynecology
Montgomery, Ohio, 45242, United States
OB/GYN Associates of Erie
Erie, Pennsylvania, 16507, United States
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, 37412, United States
Paramount Research Solutions-Nashville
Nashville, Tennessee, 37203, United States
Gadolin Research
Beaumont, Texas, 77702, United States
South Texas Clinical Research
Corpus Christi, Texas, 78404, United States
Discovery Clinical Trials - Dallas
Dallas, Texas, 75231, United States
Progressive Women's Health Pllc
Friendswood, Texas, 77546, United States
Biopharma Informatic - West Houston
Houston, Texas, 77043, United States
UTHealth Womens Research Program | Memorial City
Houston, Texas, 77054, United States
Chemidox Clinical Trials, Houston
Houston, Texas, 77071, United States
Maximos Ob/Gyn
League City, Texas, 77573, United States
AIH Research- Broadway
Pearland, Texas, 77584, United States
UVA Health Midlife Health and Gynecologic Specialties Northridge
Charlottesville, Virginia, 22903, United States
Inova Fairfax Hospital - OBGYN
Falls Church, Virginia, 22042, United States
Virginia Women's Health Associates
Reston, Virginia, 20190, United States
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, K1H 7W9, Canada
Sinai Health System - Obstetrics & Gynaecology, General Obs Gyn
Toronto, Ontario, M5G 1Z5, Canada
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, 401147, China
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, TBC, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, 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
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking Union Medical College Hospital CAMS
Beijing, 100730, China
Foshan Women and Child Health Care Hospital
Foshan, 528000, China
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, 510630, China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, 210011, China
Tangshan Maternal and Child Health Care Hospital
Tangshan, 063014, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 (Estimated)
August 2, 2027
Study Completion (Estimated)
August 2, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04
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.