Clinical trial NCT06904274: A Study to Learn How Well Mirena Works as Compared to Oral Progestin in Nonatypical Endometrial Hyperplasia in Women Who Have Started Their Periods
Official title: A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Post-menarchal Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Progestin for 6 Months
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Endometrial Hyperplasia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Proportion of participants with Complete Resolution (CR) of NAEH
timeFrame: At 6 months
Secondary outcomes:
measure: Recurrence of NAEH after CR
timeFrame: At 3 months follow up after 6 months treatment
measure: Progression after CR
timeFrame: At 3 months follow up after 6 months treatment
measure: Proportion of participants having hysterectomy
timeFrame: During treatment and 3 months follow up
measure: Diagnosis of "benign endometrium"
timeFrame: At 6 months of treatment followed by 3 month treatment-free follow up
measure: Number of participants with adverse events
timeFrame: From the signing of the informed consent form (ICF) up to 3 months after the last dose of study intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile
state: Alabama
city: Mobile
country: United States
facility: AMR - Mobile, AL
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists | Research Department
state: Arizona
city: Little Rock
country: United States
facility: Cornerstone Clinic for Women
state: Arkansas
city: Burbank
country: United States
facility: Velvet Clinical Research
state: California
city: Gardena
country: United States
facility: Allen Clinical Research LLC
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Fort Myers
country: United States
facility: AMR - Fort Myers, FL
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc. | Hialeah, FL
state: Florida
city: Panama City
country: United States
facility: Emerald Coast Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research LLC | Sarasota, FL
state: Florida
city: College Park
country: United States
facility: Paramount Research Solutions | College Park Location
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates, PA
state: Idaho
city: Newburgh
country: United States
facility: Office of Dr. Cindy Basinski, LLC
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates | Metairie, LA
state: Louisiana
city: Shreveport
country: United States
facility: Gynecologic Oncology Associates
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center - Obstetrics and Gynecology
state: Maryland
city: Dearborn Heights
country: United States
facility: Revive Research Institute - Michigan - Women's Health
state: Michigan
city: Jackson
country: United States
facility: St. Dominic's Gynecology/Oncology
state: Mississippi
city: Papillion
country: United States
facility: McGill Family Practice
state: Nebraska
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc. | Las Vegas, NV
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School - OBGYN
state: New Jersey
city: Albuquerque
country: United States
facility: Bosque Women's Care | Albuquerque, NM
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Park - Eastchester - OBGYN
state: New York
city: Durham
country: United States
facility: Reply OBGYN and Fertility PLLC
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research - Wendover
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research | Raleigh, NC
state: North Carolina
city: Columbus
country: United States
facility: ClinOhio Research Services, LLC. | Columbus, OH
state: Ohio
city: Erie
country: United States
facility: OB/GYN Associates of Erie
state: Pennsylvania
city: Oaks
country: United States
facility: Axia Women's Health
state: Pennsylvania
city: Chattanooga
country: United States
facility: Galen Obstetrics And Gynecology Ridgeside
state: Tennessee
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials - Dallas
state: Texas
city: Houston
country: United States
facility: Advances in Health, INC. | Houston, TX
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio - UT Health Medical Arts & Research Center (MARC)
state: Texas
city: Charlottesville
country: United States
facility: The Woman's Place - Midlife Health
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital - OBGYN
state: Virginia
city: Xiamen
country: China
facility: Xiamen Maternity and Child Health Care Hospital
state: Fujian
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Qingdao
country: China
facility: Women and Children's Hospital, Qingdao University
state: Shandong
city: Chengdu
country: China
facility: Chengdu Women & Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital CAMS
city: Chongqing
country: China
facility: Chongqing Maternal and Child Health Care Hospital
city: Nanjing
country: China
facility: Nanjing Medical University (NMU) - The Second Affiliated Hospital
city: Tangshan
country: China
facility: Tangshan Maternal and Child Health Care Hospital
Study officials:
References: