Actively Recruiting
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Led by Bayer · Updated on 2026-04-30
207
Participants Needed
86
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menarchal women aged 18 years or older at the time of signing informed consent
- Women with histologically confirmed nonatypical endometrial hyperplasia regardless of parity or menopausal status
- Endometrial samples obtained at screening or within 42 days before informed consent
You will not qualify if you...
- Any disease or condition that may interfere with study conduct or result interpretation
- Congenital or acquired uterine or cervical abnormalities, including fibroids or cervical stenosis, that would prevent intrauterine system insertion or retention
- Use of long-acting injectable sex hormones within 6 months or short-acting hormonal medication within 6 weeks before study start
- Pregnancy
- Known family or personal history of genetic predisposition to uterine, ovarian, or colorectal cancers such as Lynch syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
UAB Medicine Center for Research in Women's Health
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Women's Health Alliance of Mobile
Mobile, Alabama, United States, 36604
Not Yet Recruiting
3
AMR - Mobile, AL
Mobile, Alabama, United States, 36608
Not Yet Recruiting
4
Velocity Clinical Research - Mobile
Mobile, Alabama, United States, 36608
Not Yet Recruiting
5
North Valley Women's Care
Glendale, Arizona, United States, 85308
Not Yet Recruiting
6
Mesa Obstetricians and Gynecologists | Research Department
Mesa, Arizona, United States, 85206
Withdrawn
7
Marchand OB/GYN
Mesa, Arizona, United States, 85209
Not Yet Recruiting
8
Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
9
Cornerstone Clinic for Women - Aldersgate
Little Rock, Arkansas, United States, 72205
Actively Recruiting
10
Velvet Clinical Research
Burbank, California, United States, 91506
Not Yet Recruiting
11
Allen Clinical Research LLC
Gardena, California, United States, 90247
Not Yet Recruiting
12
UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN
Sacramento, California, United States, 95817
Not Yet Recruiting
13
Alliance Clinical West Hills
West Hills, California, United States, 91307
Actively Recruiting
14
OB/GYN Department_Comprehensive Women's Health Center
Denver, Colorado, United States, 80230
Not Yet Recruiting
15
AMR - Fort Myers, FL
Fort Myers, Florida, United States, 33912
Not Yet Recruiting
16
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, United States, 33016
Not Yet Recruiting
17
UF Health Women's Specialists - Emerson
Jacksonville, Florida, United States, 32207
Not Yet Recruiting
18
New Age Medical Research Corp.
Miami, Florida, United States, 33186
Not Yet Recruiting
19
K2 Medical Research - South Orlando
Orlando, Florida, United States, 32751
Not Yet Recruiting
20
Entrust Clinical Research
Palmetto Bay, Florida, United States, 33176
Actively Recruiting
21
Emerald Coast Clinical Research
Panama City, Florida, United States, 32405
Actively Recruiting
22
Physician Care Clinical Research LLC | Sarasota, FL
Sarasota, Florida, United States, 34239
Not Yet Recruiting
23
USF Health South Tampa Center for Advanced Healthcare - Gynecology
Tampa, Florida, United States, 33606
Not Yet Recruiting
24
Paramount Research Solutions | College Park Location
Atlanta, Georgia, United States, 30327
Actively Recruiting
25
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
26
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
27
Women's Wellness / SKYCRNG
Chicago, Illinois, United States, 60644
Withdrawn
28
Office of Dr. Cindy Basinski, LLC
Evansville, Indiana, United States, 47715
Actively Recruiting
29
McFarland Clinic - Medical Arts Building - OBGYN
Ames, Iowa, United States, 50010
Not Yet Recruiting
30
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States, 70508
Not Yet Recruiting
31
Southern Clinical Research Associates
Metairie, Louisiana, United States, 70001
Actively Recruiting
32
Gynecologic Oncology Associates
Shreveport, Louisiana, United States, 71103
Withdrawn
33
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States, 71118
Actively Recruiting
34
The Levi Watkins Jr. MD Outpatient Center - Obstetrics and Gynecology
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
35
Tufts Medical Center - OB/GYN
Boston, Massachusetts, United States, 02111
Not Yet Recruiting
36
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, United States, 48127
Actively Recruiting
37
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Not Yet Recruiting
38
St. Dominic's Gynecology/Oncology
Jackson, Mississippi, United States, 39216
Not Yet Recruiting
39
SKY integrative Medical Center
Ridgeland, Mississippi, United States, 39157
Withdrawn
40
McGill Family Practice
Papillion, Nebraska, United States, 68046
Not Yet Recruiting
41
Affiliated Clinical Research, Inc. | Las Vegas, NV
Las Vegas, Nevada, United States, 89113
Not Yet Recruiting
42
Elite Clinical Network (ECN) | Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States, 89030
Not Yet Recruiting
43
Rutgers Robert Wood Johnson Medical School - OBGYN
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
44
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
45
Columbia University Medical Center - Gynecology
New York, New York, United States, 10032
Withdrawn
46
Montefiore Medical Park - Eastchester - OBGYN
The Bronx, New York, United States, 10461
Not Yet Recruiting
47
Reply OBGYN and Fertility PLLC
Durham, North Carolina, United States, 27713
Withdrawn
48
Unified Women's Clinical Research - Centre OB/GYN
Raleigh, North Carolina, United States, 27607
Actively Recruiting
49
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
50
TriHealth Women's Servies - Seven Hills Women's Health Center
Cincinnati, Ohio, United States, 45255
Not Yet Recruiting
51
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, United States, 43213
Not Yet Recruiting
52
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
Mayfield Heights, Ohio, United States, 44124
Not Yet Recruiting
53
Bethesda North Hospital - Gynecology
Montgomery, Ohio, United States, 45242
Not Yet Recruiting
54
OB/GYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Actively Recruiting
55
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, United States, 37412
Actively Recruiting
56
Paramount Research Solutions-Nashville
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
57
Gadolin Research
Beaumont, Texas, United States, 77702
Not Yet Recruiting
58
South Texas Clinical Research
Corpus Christi, Texas, United States, 78404
Not Yet Recruiting
59
Discovery Clinical Trials - Dallas
Dallas, Texas, United States, 75231
Actively Recruiting
60
Progressive Women's Health Pllc
Friendswood, Texas, United States, 77546
Not Yet Recruiting
61
Biopharma Informatic - West Houston
Houston, Texas, United States, 77043
Actively Recruiting
62
UTHealth Womens Research Program | Memorial City
Houston, Texas, United States, 77054
Not Yet Recruiting
63
Chemidox Clinical Trials, Houston
Houston, Texas, United States, 77071
Not Yet Recruiting
64
Maximos Ob/Gyn
League City, Texas, United States, 77573
Not Yet Recruiting
65
AIH Research- Broadway
Pearland, Texas, United States, 77584
Actively Recruiting
66
UVA Health Midlife Health and Gynecologic Specialties Northridge
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
67
Inova Fairfax Hospital - OBGYN
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
68
Virginia Women's Health Associates
Reston, Virginia, United States, 20190
Not Yet Recruiting
69
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, Canada, K1H 7W9
Not Yet Recruiting
70
Sinai Health System - Obstetrics & Gynaecology, General Obs Gyn
Toronto, Ontario, Canada, M5G 1Z5
Not Yet Recruiting
71
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada, G8T 7A1
Not Yet Recruiting
72
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, China, 401147
Actively Recruiting
73
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, China, TBC
Actively Recruiting
74
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
75
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Not Yet Recruiting
76
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
77
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
78
Women and Children's Hospital, Qingdao University - Gynecology department
Qingdao, Shandong, China, 266034
Actively Recruiting
79
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, China, 610091
Actively Recruiting
80
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
81
China-Japan Friendship Hospital
Beijing, China, 100029
Not Yet Recruiting
82
Peking Union Medical College Hospital CAMS
Beijing, China, 100730
Actively Recruiting
83
Foshan Women and Child Health Care Hospital
Foshan, China, 528000
Not Yet Recruiting
84
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, China, 510630
Not Yet Recruiting
85
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, China, 210011
Actively Recruiting
86
Tangshan Maternal and Child Health Care Hospital
Tangshan, China, 063014
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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