Actively Recruiting
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
Led by Bayer · Updated on 2026-05-27
207
Participants Needed
87
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for women with nonatypical endometrial hyperplasia (NAEH), a condition where the lining of the uterus becomes too thick but is not cancerous. This condition, often caused by hormone imbalances, can lead to abnormal vaginal bleeding or irregular periods and may progress to cancer if untreated. Currently, no approved treatments exist, so this study aims to find better options. The main goal is to see if treatment with Mirena or oral medroxyprogesterone acetate (MPA) can restore the uterine lining to normal and be safe for participants. Participants will be randomly assigned in a 2:1 ratio to receive either Mirena, a device inserted into the uterus that releases progesterone, or daily oral MPA tablets for six months. Mirena is inserted at the start of treatment and removed after six months or earlier if the participant stops the study. Those taking oral MPA will take a 10 mg tablet once daily during the treatment period. Treatment lasts for six months, followed by a three-month observation without treatment. Participants will be involved for about 10 months, including up to five clinic visits: one before treatment starts, three during treatment spaced three months apart, and one after treatment ends. During visits, doctors will monitor health through blood and urine tests, vaginal ultrasound, hysteroscopy (a minor procedure to view the womb and collect tissue samples), and questions about symptoms and any medical issues. The study tracks the proportion of participants whose uterine lining returns to normal at six months, as well as monitoring for recurrence, progression, and any side effects.
CONDITIONS
Brief 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 the informed consent.
- Women with histologically confirmed nonatypical endometrial hyperplasia regardless of parity or menopausal status.
- Endometrial samples must be obtained at screening or no more than 42 days before signing the informed consent form.
You will not qualify if you...
- Any diseases or conditions that could interfere with the study conduct or result interpretation.
- Congenital or acquired uterine or cervical anomalies such as fibroids or cervical stenosis that may affect insertion or retention of the intrauterine system.
- Use of long-acting injectable sex-hormone treatments within 6 months prior to study start, or short-acting hormonal medications within 6 weeks prior to study start.
- Pregnancy.
- Known personal or family history of genetic predisposition to uterine, ovarian, or colorectal cancers (e.g., Lynch syndrome).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive either the Mirena intrauterine system inserted by the investigator or take 10mg oral progestin once daily for 6 months.
4 visits including insertion and removal visits for Mirena group; regular visits for oral medication group
Duration - 3 months
Participants are monitored for recurrence or progression of nonatypical endometrial hyperplasia after treatment ends.
1 follow-up visit after treatment completion
Trial Site Locations
Total: 87 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
Zillan Clinical Research
Inglewood, California, United States, 90303
Not Yet Recruiting
13
UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN
Sacramento, California, United States, 95817
Not Yet Recruiting
14
Alliance Clinical West Hills
West Hills, California, United States, 91307
Actively Recruiting
15
OB/GYN Department_Comprehensive Women's Health Center
Denver, Colorado, United States, 80230
Not Yet Recruiting
16
AMR - Fort Myers, FL
Fort Myers, Florida, United States, 33912
Not Yet Recruiting
17
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, United States, 33016
Actively Recruiting
18
UF Health Women's Specialists - Emerson
Jacksonville, Florida, United States, 32207
Not Yet Recruiting
19
New Age Medical Research Corp.
Miami, Florida, United States, 33186
Not Yet Recruiting
20
K2 Medical Research - South Orlando
Orlando, Florida, United States, 32751
Withdrawn
21
Entrust Clinical Research
Palmetto Bay, Florida, United States, 33176
Actively Recruiting
22
Emerald Coast Clinical Research
Panama City, Florida, United States, 32405
Actively Recruiting
23
Physician Care Clinical Research LLC | Sarasota, FL
Sarasota, Florida, United States, 34239
Not Yet Recruiting
24
USF Health South Tampa Center for Advanced Healthcare - Gynecology
Tampa, Florida, United States, 33606
Not Yet Recruiting
25
Paramount Research Solutions | College Park Location
Atlanta, Georgia, United States, 30327
Actively Recruiting
26
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
27
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
28
Women's Wellness / SKYCRNG
Chicago, Illinois, United States, 60644
Withdrawn
29
Office of Dr. Cindy Basinski, LLC
Evansville, Indiana, United States, 47715
Actively Recruiting
30
McFarland Clinic - Medical Arts Building - OBGYN
Ames, Iowa, United States, 50010
Not Yet Recruiting
31
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States, 70508
Not Yet Recruiting
32
Southern Clinical Research Associates
Metairie, Louisiana, United States, 70001
Actively Recruiting
33
Gynecologic Oncology Associates
Shreveport, Louisiana, United States, 71103
Withdrawn
34
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States, 71118
Actively Recruiting
35
The Levi Watkins Jr. MD Outpatient Center - Obstetrics and Gynecology
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
36
Tufts Medical Center - OB/GYN
Boston, Massachusetts, United States, 02111
Not Yet Recruiting
37
Revive Research Institute - Michigan - Women's Health
Dearborn Heights, Michigan, United States, 48127
Actively Recruiting
38
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Not Yet Recruiting
39
St. Dominic's Gynecology/Oncology
Jackson, Mississippi, United States, 39216
Not Yet Recruiting
40
SKY integrative Medical Center
Ridgeland, Mississippi, United States, 39157
Withdrawn
41
McGill Family Practice
Papillion, Nebraska, United States, 68046
Not Yet Recruiting
42
Affiliated Clinical Research, Inc. | Las Vegas, NV
Las Vegas, Nevada, United States, 89113
Not Yet Recruiting
43
Elite Clinical Network (ECN) | Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, United States, 89030
Not Yet Recruiting
44
Rutgers Robert Wood Johnson Medical School - OBGYN
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
45
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
46
Columbia University Medical Center - Gynecology
New York, New York, United States, 10032
Withdrawn
47
Montefiore Medical Park - Eastchester - OBGYN
The Bronx, New York, United States, 10461
Not Yet Recruiting
48
Reply OBGYN and Fertility PLLC
Durham, North Carolina, United States, 27713
Withdrawn
49
Unified Women's Clinical Research - Centre OB/GYN
Raleigh, North Carolina, United States, 27607
Actively Recruiting
50
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
51
TriHealth Women's Servies - Seven Hills Women's Health Center
Cincinnati, Ohio, United States, 45255
Not Yet Recruiting
52
ClinOhio Research Services, LLC. | Columbus, OH
Columbus, Ohio, United States, 43213
Not Yet Recruiting
53
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
Mayfield Heights, Ohio, United States, 44124
Not Yet Recruiting
54
Velocity Clinical Research - Blue Ash, Cincinnati
Montgomery, Ohio, United States, 45242
Not Yet Recruiting
55
OB/GYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Actively Recruiting
56
Chattanooga Medical Research, LLC. | Chattanooga, TN
Chattanooga, Tennessee, United States, 37412
Actively Recruiting
57
Paramount Research Solutions-Nashville
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
58
Gadolin Research
Beaumont, Texas, United States, 77702
Not Yet Recruiting
59
South Texas Clinical Research
Corpus Christi, Texas, United States, 78404
Not Yet Recruiting
60
Discovery Clinical Trials - Dallas
Dallas, Texas, United States, 75231
Actively Recruiting
61
Progressive Women's Health Pllc
Friendswood, Texas, United States, 77546
Not Yet Recruiting
62
Biopharma Informatic - West Houston
Houston, Texas, United States, 77043
Actively Recruiting
63
UTHealth Womens Research Program | Memorial City
Houston, Texas, United States, 77054
Not Yet Recruiting
64
Chemidox Clinical Trials, Houston
Houston, Texas, United States, 77071
Not Yet Recruiting
65
Maximos Ob/Gyn
League City, Texas, United States, 77573
Not Yet Recruiting
66
AIH Research- Broadway
Pearland, Texas, United States, 77584
Actively Recruiting
67
UVA Health Midlife Health and Gynecologic Specialties Northridge
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
68
Inova Fairfax Hospital - OBGYN
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
69
Virginia Women's Health Associates
Reston, Virginia, United States, 20190
Not Yet Recruiting
70
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
Ottawa, Ontario, Canada, K1H 7W9
Not Yet Recruiting
71
Mount Sinai Hospital Toronto | Gynecology
Toronto, Ontario, Canada, M5G 1Z5
Not Yet Recruiting
72
Centres Investigation Clinique Mauricie
Trois-Rivières, Quebec, Canada, G8T 7A1
Actively Recruiting
73
Chongqing Maternal and Child Health Care Hospital
Chongqing, Chongqing Municipality, China, 401147
Actively Recruiting
74
Xiamen Maternity and Child Health Care Hospital - Gynecology Department
Xiamen, Fujian, China, TBC
Actively Recruiting
75
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
76
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Not Yet Recruiting
77
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
78
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
79
Women and Children's Hospital, Qingdao University - Gynecology department
Qingdao, Shandong, China, 266034
Actively Recruiting
80
Chengdu Women & Children's Central Hospital
Chengdu, Sichuan, China, 610091
Actively Recruiting
81
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
82
China-Japan Friendship Hospital
Beijing, China, 100029
Not Yet Recruiting
83
Peking Union Medical College Hospital CAMS
Beijing, China, 100730
Actively Recruiting
84
Foshan Women and Child Health Care Hospital
Foshan, China, 528000
Not Yet Recruiting
85
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
Guangzhou, China, 510630
Actively Recruiting
86
Nanjing Medical University (NMU) - The Second Affiliated Hospital
Nanjing, China, 210011
Actively Recruiting
87
Tangshan Maternal and Child Health Care Hospital
Tangshan, China, 063014
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials 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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