Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
NCT ID: NCT06904274
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
207 participants
INTERVENTIONAL
2025-12-01
2027-01-20
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levonorgestrel (BAY865028, Mirena)
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.
BAY865028
Intrauterine delivery system
Oral progestin
Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).
Medroxyprogesterone acetate
Oral tablet
Interventions
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BAY865028
Intrauterine delivery system
Medroxyprogesterone acetate
Oral tablet
Eligibility Criteria
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Inclusion Criteria
* Women with histologically confirmed NAEH independent of their parity or menopausal status.
Exclusion Criteria
* 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).
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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UAB Medicine Center for Research in Women's Health
Birmingham, Alabama, United States
Women's Health Alliance of Mobile
Mobile, Alabama, United States
AMR - Mobile, AL
Mobile, Alabama, United States
Velocity Clinical Research - Mobile
Mobile, Alabama, United States
North Valley Women's Care
Glendale, Arizona, United States
Mesa Obstetricians and Gynecologists | Research Department
Mesa, Arizona, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States
Cornerstone Clinic for Women
Little Rock, Arkansas, United States
Velvet Clinical Research
Burbank, California, United States
Allen Clinical Research LLC
Gardena, California, United States
UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN
Sacramento, California, United States
Alliance Clinical West Hills
West Hills, California, United States
AMR - Fort Myers, FL
Fort Myers, Florida, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, United States
UF Health Women's Specialists - Emerson
Jacksonville, Florida, United States
K2 Medical Research - South Orlando
Orlando, Florida, United States
Entrust Clinical Research
Palmetto Bay, Florida, United States
Emerald Coast Clinical Research
Panama City, Florida, United States
Physician Care Clinical Research LLC | Sarasota, FL
Sarasota, Florida, United States
USF Health South Tampa Center for Advanced Healthcare - Gynecology
Tampa, Florida, United States
Paramount Research Solutions | College Park Location
College Park, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Women's Healthcare Associates, PA
Idaho Falls, Idaho, United States
Women's Wellness / SKYCRNG
Chicago, Illinois, United States
Office of Dr. Cindy Basinski, LLC
Newburgh, Indiana, United States
McFarland Clinic - Medical Arts Building - OBGYN
Ames, Iowa, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Gynecologic Oncology Associates
Shreveport, Louisiana, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States
Johns Hopkins Outpatient Center - Obstetrics and Gynecology
Baltimore, Maryland, United States
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, United States
Hutzel Women's Hospital
Detroit, Michigan, United States
St. Dominic's Gynecology/Oncology
Jackson, Mississippi, United States
SKY integrative Medical Center
Ridgeland, Mississippi, United States
McGill Family Practice
Papillion, Nebraska, United States
Affiliated Clinical Research, Inc. | Las Vegas, NV
Las Vegas, Nevada, United States
Rutgers Robert Wood Johnson Medical School - OBGYN
New Brunswick, New Jersey, United States
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, United States
Columbia University Medical Center - Gynecology
New York, New York, United States
Montefiore Medical Park - Eastchester - OBGYN
The Bronx, New York, United States
Reply OBGYN and Fertility PLLC
Durham, North Carolina, United States
Centre OB/GYN
Raleigh, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Axia Women's Health - Anderson Township
Cincinnati, Ohio, United States
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, United States
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
Mayfield Heights, Ohio, United States
Bethesda North Hospital - Gynecology
Montgomery, Ohio, United States
OB/GYN Associates of Erie
Erie, Pennsylvania, United States
Galen Obstetrics And Gynecology Ridgeside
Chattanooga, Tennessee, United States
Paramount Research Solutions-Nashville
Nashville, Tennessee, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
Discovery Clinical Trials - Dallas
Dallas, Texas, United States
Progressive Women's Health Pllc
Friendswood, Texas, United States
Biopharma Informatic - West Houston
Houston, Texas, United States
Advances in Health, INC. | Houston, TX
Houston, Texas, United States
UTHealth Womens Research Program | Memorial City
Houston, Texas, United States
UVA Health Midlife Health and Gynecologic Specialties Northridge
Charlottesville, Virginia, United States
Inova Fairfax Hospital - OBGYN
Falls Church, Virginia, United States
Virginia Women's Health Associates
Reston, Virginia, United States
Xiamen Maternity and Child Health Care Hospital
Xiamen, Fujian, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Women and Children's Hospital, Qingdao University
Qingdao, Shandong, China
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
China-Japan Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital CAMS
Beijing, , China
Chongqing Maternal and Child Health Care Hospital
Chongqing, , China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, , China
Tangshan Maternal and Child Health Care Hospital
Tangshan, , China
Countries
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Central Contacts
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.
Other Identifiers
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22923
Identifier Type: -
Identifier Source: org_study_id