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

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
UAB Medicine Center for Research in Women's Health
NOT_YET_RECRUITING
Birmingham
AMR - Mobile, AL
NOT_YET_RECRUITING
Mobile
Velocity Clinical Research - Mobile
NOT_YET_RECRUITING
Mobile
Women's Health Alliance of Mobile
NOT_YET_RECRUITING
Mobile
Arkansas
Cornerstone Clinic for Women - Aldersgate
RECRUITING
Little Rock
Arizona
North Valley Women's Care
NOT_YET_RECRUITING
Glendale
Mesa Obstetricians and Gynecologists | Research Department
WITHDRAWN
Mesa
Velocity Clinical Research - Phoenix
NOT_YET_RECRUITING
Phoenix
California
Velvet Clinical Research
NOT_YET_RECRUITING
Burbank
Allen Clinical Research LLC
NOT_YET_RECRUITING
Gardena
UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN
NOT_YET_RECRUITING
Sacramento
Alliance Clinical West Hills
NOT_YET_RECRUITING
West Hills
Colorado
OB/GYN Department_Comprehensive Women's Health Center
NOT_YET_RECRUITING
Denver
Florida
AMR - Fort Myers, FL
NOT_YET_RECRUITING
Fort Myers
Sweet Hope Research Specialty, Inc. - Hialeah
NOT_YET_RECRUITING
Hialeah
UF Health Women's Specialists - Emerson
NOT_YET_RECRUITING
Jacksonville
K2 Medical Research - South Orlando
NOT_YET_RECRUITING
Orlando
Entrust Clinical Research
NOT_YET_RECRUITING
Palmetto Bay
Emerald Coast Clinical Research
NOT_YET_RECRUITING
Panama City
Physician Care Clinical Research LLC | Sarasota, FL
NOT_YET_RECRUITING
Sarasota
USF Health South Tampa Center for Advanced Healthcare - Gynecology
NOT_YET_RECRUITING
Tampa
Georgia
Paramount Research Solutions | College Park Location
NOT_YET_RECRUITING
College Park
Iowa
McFarland Clinic - Medical Arts Building - OBGYN
NOT_YET_RECRUITING
Ames
Idaho
Clinical Research Prime
NOT_YET_RECRUITING
Idaho Falls
Women's Healthcare Associates, PA
NOT_YET_RECRUITING
Idaho Falls
Illinois
Women's Wellness / SKYCRNG
NOT_YET_RECRUITING
Chicago
Indiana
Office of Dr. Cindy Basinski, LLC
NOT_YET_RECRUITING
Newburgh
Louisiana
Velocity Clinical Research - Lafayette
NOT_YET_RECRUITING
Lafayette
Southern Clinical Research Associates
NOT_YET_RECRUITING
Metairie
Gynecologic Oncology Associates
WITHDRAWN
Shreveport
Omni Fertility and Laser Institute
NOT_YET_RECRUITING
Shreveport
Maryland
Johns Hopkins Outpatient Center - Obstetrics and Gynecology
NOT_YET_RECRUITING
Baltimore
Michigan
Revive Research Institute - Michigan - Women's Health
NOT_YET_RECRUITING
Dearborn Heights
Hutzel Women's Hospital
NOT_YET_RECRUITING
Detroit
Mississippi
St. Dominic's Gynecology/Oncology
NOT_YET_RECRUITING
Jackson
SKY integrative Medical Center
NOT_YET_RECRUITING
Ridgeland
North Carolina
Reply OBGYN and Fertility PLLC
WITHDRAWN
Durham
Centre OB/GYN
NOT_YET_RECRUITING
Raleigh
Lyndhurst Clinical Research
NOT_YET_RECRUITING
Winston-salem
Nebraska
McGill Family Practice
NOT_YET_RECRUITING
Papillion
New Jersey
Rutgers Robert Wood Johnson Medical School - OBGYN
NOT_YET_RECRUITING
New Brunswick
New Mexico
Bosque Women's Care | Albuquerque, NM
NOT_YET_RECRUITING
Albuquerque
Nevada
Affiliated Clinical Research, Inc. | Las Vegas, NV
NOT_YET_RECRUITING
Las Vegas
New York
Columbia University Medical Center - Gynecology
NOT_YET_RECRUITING
New York
Montefiore Medical Park - Eastchester - OBGYN
NOT_YET_RECRUITING
The Bronx
Ohio
Axia Women's Health - Anderson Township
NOT_YET_RECRUITING
Cincinnati
ClinOhio Research Services, LLC. | Columbus, OH
NOT_YET_RECRUITING
Columbus
University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit
NOT_YET_RECRUITING
Mayfield Heights
Bethesda North Hospital - Gynecology
NOT_YET_RECRUITING
Montgomery
Pennsylvania
OB/GYN Associates of Erie
NOT_YET_RECRUITING
Erie
Tennessee
Galen Obstetrics And Gynecology Ridgeside
NOT_YET_RECRUITING
Chattanooga
Paramount Research Solutions-Nashville
NOT_YET_RECRUITING
Nashville
Texas
South Texas Clinical Research
NOT_YET_RECRUITING
Corpus Christi
Discovery Clinical Trials - Dallas
NOT_YET_RECRUITING
Dallas
Progressive Women's Health Pllc
NOT_YET_RECRUITING
Friendswood
Biopharma Informatic - West Houston
NOT_YET_RECRUITING
Houston
UTHealth Womens Research Program | Memorial City
NOT_YET_RECRUITING
Houston
AIH Research- Broadway
NOT_YET_RECRUITING
Pearland
Virginia
UVA Health Midlife Health and Gynecologic Specialties Northridge
NOT_YET_RECRUITING
Charlottesville
Inova Fairfax Hospital - OBGYN
NOT_YET_RECRUITING
Falls Church
Virginia Women's Health Associates
NOT_YET_RECRUITING
Reston
Other Locations
Canada
The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care
NOT_YET_RECRUITING
Ottawa
Sinai Health System - Obstetrics & Gynaecology, General Obs Gyn
NOT_YET_RECRUITING
Toronto
Centres Investigation Clinique Mauricie
NOT_YET_RECRUITING
Trois-rivières
China
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital CAMS
NOT_YET_RECRUITING
Beijing
Chengdu Women & Children's Central Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing Maternal and Child Health Care Hospital
NOT_YET_RECRUITING
Chongqing
Foshan Women and Child Health Care Hospital
NOT_YET_RECRUITING
Foshan
The Third Affiliated Hospital of Southern Medical University - Gynecology Department
NOT_YET_RECRUITING
Guangzhou
Women's Hospital School of Medicine Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Jiangxi Maternal and Child Health Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing Maternity and Child Health Care Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Medical University (NMU) - The Second Affiliated Hospital
NOT_YET_RECRUITING
Nanjing
Women and Children's Hospital, Qingdao University
NOT_YET_RECRUITING
Qingdao
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
Tangshan Maternal and Child Health Care Hospital
NOT_YET_RECRUITING
Tangshan
Shaanxi Provincial People's Hospital
NOT_YET_RECRUITING
Xi'an
Xiamen Maternity and Child Health Care Hospital
NOT_YET_RECRUITING
Xiamen
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-05-03
Participants
Target number of participants: 207
Treatments
Experimental: 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.
Active_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov