Endometrial HyperplasiaPhase 3SUNFLOWERNCT06904274
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
A Phase 3 study testing BAY865028 and Medroxyprogesterone acetate in people with Endometrial Hyperplasia, run by Bayer at 38 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Hyperplasia
- What is being tested?
- BAY865028 and Medroxyprogesterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 24 Nov 2025to 17 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States22 sites
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109
Paramount Research Solutions | College Park Location
Atlanta, Georgia, 30327
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, 37412
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, 43213
Discovery Clinical Trials - Dallas
Dallas, Texas, 75230
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, 48127
OB/GYN Associates of Erie
Erie, Pennsylvania, 16507
Office of Dr. Cindy Basinski, LLC
Evansville, Indiana, 47715
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, 33016
Biopharma Informatic - West Houston
Houston, Texas, 77043
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
Cornerstone Clinic for Women - Aldersgate
Little Rock, Arkansas, 72205
Southern Clinical Research Associates
Metairie, Louisiana, 70001
New Age Medical Research Corp.
Miami, Florida, 33186
Entrust Clinical Research
Palmetto Bay, Florida, 33176
Emerald Coast Clinical Research
Panama City, Florida, 32405
AIH Research- Broadway
Pearland, Texas, 77584
Velocity Clinical Research - Phoenix
Phoenix, Arizona, 85006
Unified Women's Clinical Research - Centre OB/GYN
Raleigh, North Carolina, 27607
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118
Alliance Clinical West Hills
West Hills, California, 91307
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
China13 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking Union Medical College Hospital CAMS
Beijing, Beijing Municipality, 100730
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, 610091
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, 401147
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, Guangdong, 510630
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, Jiangsu, 210011
Women and Children's Hospital, Qingdao University - Gynecology department
Qingdao, Shandong, 266034
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Tangshan Maternal and Child Health Care Hospital
Tangshan, Hebei, 063014
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, 361003
Canada3 sites
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, K1H 7W9
Mount Sinai Hospital Toronto | Gynecology
Toronto, Ontario, M5G 1Z5
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, G8T 7A1
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Endometrial Hyperplasia
- Being tested
- BAY865028, Medroxyprogesterone acetate
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY865028Combination product
Intrauterine delivery system
Medroxyprogesterone acetateDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel (BAY865028, Mirena) | Experimental | 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. Receives: Combination Product: BAY865028 |
| Oral progestin | Active comparator | Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months). Receives: Drug: Medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Complete Resolution (CR) of NAEH
Complete Resolution will be evaluated as benign endometrium.
Measured: At 6 months
Secondary outcomes (5)
Recurrence of NAEH after CR
Recurrence of NAEH on 3 months treatment free after CR at 6 months
Measured: At 3 months follow up after 6 months treatment
Progression after CR
Endometrial hyperplasia with atypia or endometrial cancer after 3 months treatment free follow up after CR at 6 months
Measured: At 3 months follow up after 6 months treatment
Proportion of participants having hysterectomy
Measured: During treatment and 3 months follow up
Diagnosis of "benign endometrium"
Measured: At 6 months of treatment followed by 3 month treatment-free follow up
Number of participants with adverse events
All AEs will be coded using the latest version prior to database lock of the Medical Dictionary for Regulatory Activities
Measured: From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start24 Nov 2025
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904274
- Sponsor's protocol ID
- 22923
- Acronym
- SUNFLOWER
- Status last verified
- 22 Jul 2026
- First submitted
- 21 Mar 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06904274
- Acronym / sponsor ID
- SUNFLOWER / 22923
- Conditions
- Endometrial Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel (BAY865028, Mirena) | Experimental | Combination Product: BAY865028Mirena 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 comparator | Drug: Medroxyprogesterone acetateParticipants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY865028Intrauterine delivery system | Combination product | Levonorgestrel (BAY865028, Mirena) |
| Medroxyprogesterone acetateOral tablet | Drug | Oral progestin |
Primary outcome
Proportion of participants with Complete Resolution (CR) of NAEH
Time frame: At 6 months
Complete Resolution will be evaluated as benign endometrium.
5 secondary outcomes
Recurrence of NAEH after CR
Time frame: At 3 months follow up after 6 months treatment
Progression after CR
Time frame: At 3 months follow up after 6 months treatment
Proportion of participants having hysterectomy
Time frame: During treatment and 3 months follow up
Diagnosis of "benign endometrium"
Time frame: At 6 months of treatment followed by 3 month treatment-free follow up
Number of participants with adverse events
Time frame: From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Endometrial Hyperplasia
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Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
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Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
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RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BAY865028 and Medroxyprogesterone acetate in people with Endometrial Hyperplasia, run by Bayer at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, China, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Complete Resolution (CR) of NAEH (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.