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Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Sponsor: Bayer
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2025-11-24
Completion Date
2027-08-02
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
BAY865028
Intrauterine delivery system
Medroxyprogesterone acetate
Oral tablet
Locations (85)
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
Marchand OB/GYN
Mesa, Arizona, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States
Cornerstone Clinic for Women - Aldersgate
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
OB/GYN Department_Comprehensive Women's Health Center
Denver, Colorado, 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
New Age Medical Research Corp.
Miami, 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
Atlanta, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Women's Wellness / SKYCRNG
Chicago, Illinois, United States
Office of Dr. Cindy Basinski, LLC
Evansville, 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
Tufts Medical Center - OB/GYN
Boston, Massachusetts, 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
Unified Women's Clinical Research - Centre OB/GYN
Raleigh, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
TriHealth Women's Servies - Seven Hills Women's Health Center
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
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, United States
Paramount Research Solutions-Nashville
Nashville, Tennessee, United States
Gadolin Research
Beaumont, Texas, 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
UTHealth Womens Research Program | Memorial City
Houston, Texas, United States
Chemidox Clinical Trials, Houston
Houston, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
AIH Research- Broadway
Pearland, 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
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, Canada
Sinai Health System - Obstetrics & Gynaecology, General Obs Gyn
Toronto, Ontario, Canada
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, China
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Women and Children's Hospital, Qingdao University - Gynecology department
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
Foshan Women and Child Health Care Hospital
Foshan, China
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, China
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, China
Tangshan Maternal and Child Health Care Hospital
Tangshan, China