A Study to Learn How Well Mirena Works as Compared to Oral Progestin in Nonatypical Endometrial Hyperplasia in Women Who Have Started Their Periods
- Conditions
- Endometrial Hyperplasia
- Interventions
- Combination Product: BAY865028
- Registration Number
- NCT06904274
- Lead Sponsor
- Bayer
- Brief 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, oral progestins (OP) which are progesterone (female hormone) capsules taken by mouth, are used to treat NAEH. However, there is still a need for other treatments due to unmet needs.
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 learn how well Mirena works compared to oral in NAEH in women who have started their periods.
For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral progestins.
The study participants will be randomly divided equally into one of two treatment groups. 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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Post-menarchal women (≥ 16-years) at the time of signing the informed consent.
- Women with histologically confirmed NAEH independent of their parity or menopausal status.
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levonorgestrel (BAY865028, Mirena) BAY865028 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. Oral progestin Medroxyprogesterone acetate Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).
- Primary Outcome Measures
Name Time Method Proportion of participants with Complete Resolution (CR) of NAEH At 6 months Complete Resolution will be evaluated as benign endometrium.
- Secondary Outcome Measures
Name Time Method Recurrence of NAEH after CR At 3 months follow up after 6 months treatment Recurrence of NAEH on 3 months treatment free after CR at 6 months
Progression after CR At 3 months follow up after 6 months treatment Endometrial hyperplasia with atypia or endometrial cancer after 3 months treatment free follow up after CR at 6 months
Proportion of participants having hysterectomy During treatment and 3 months follow up Diagnosis of "benign endometrium" At 6 months of treatment followed by 3 month treatment-free follow up Number of participants with adverse events From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention All AEs will be coded using the latest version prior to database lock of the Medical Dictionary for Regulatory Activities
Related Research Topics
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Trial Locations
- Locations (54)
Chongqing Maternal and Child Health Care Hospital
🇨🇳Chongqing, China
Axia Women's Health
🇺🇸Oaks, Pennsylvania, United States
AMR - Mobile, AL
🇺🇸Mobile, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Women's Health Alliance of Mobile
🇺🇸Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists | Research Department
🇺🇸Mesa, 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
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
AMR - Fort Myers, FL
🇺🇸Fort Myers, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Sweet Hope Research Specialty, Inc. | Hialeah, FL
🇺🇸Hialeah, Florida, United States
Emerald Coast Clinical Research
🇺🇸Panama City, Florida, United States
Physician Care Clinical Research LLC | Sarasota, FL
🇺🇸Sarasota, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Women's Healthcare Associates, PA
🇺🇸Idaho Falls, Idaho, United States
Office of Dr. Cindy Basinski, LLC
🇺🇸Newburgh, Indiana, United States
McFarland Clinic
🇺🇸Ames, Iowa, United States
Velocity Clinical Research - Lafayette
🇺🇸Lafayette, Louisiana, United States
Southern Clinical Research Associates | Metairie, LA
🇺🇸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, Inc. - Women's Health
🇺🇸Dearborn Heights, Michigan, United States
St. Dominic's Gynecology/Oncology
🇺🇸Jackson, 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
🇺🇸New Brunswick, New Jersey, United States
Bosque Women's Care | Albuquerque, NM
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Park - Eastchester - OBGYN
🇺🇸Bronx, New York, United States
Reply OBGYN and Fertility PLLC
🇺🇸Durham, North Carolina, United States
Unified Women's Clinical Research | Raleigh, NC
🇺🇸Raleigh, North Carolina, United States
Unified Women's Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
ClinOhio Research Services, LLC. | Columbus, OH
🇺🇸Columbus, Ohio, United States
OB/GYN Associates of Erie
🇺🇸Erie, Pennsylvania, United States
Galen Obstetrics And Gynecology Ridgeside
🇺🇸Chattanooga, Tennessee, United States
South Texas Clinical Research
🇺🇸Corpus Christi, Texas, United States
Discovery Clinical Trials - Dallas
🇺🇸Dallas, Texas, United States
Advances in Health, INC. | Houston, TX
🇺🇸Houston, Texas, United States
UT Health San Antonio - UT Health Medical Arts & Research Center (MARC)
🇺🇸San Antonio, Texas, United States
The Woman's Place - Midlife Health
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital - OBGYN
🇺🇸Falls Church, 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
Nanjing Medical University (NMU) - The Second Affiliated Hospital
🇨🇳Nanjing, China
Tangshan Maternal and Child Health Care Hospital
🇨🇳Tangshan, China