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
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer
- 入组人数
- 207
- 试验地点
- 161
- 主要终点
- Proportion of participants with Complete Resolution (CR) of NAEH
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: BAY865028 (Combination Product)
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).
干预措施: Medroxyprogesterone acetate (Drug)
结局指标
主要结局
Proportion of participants with Complete Resolution (CR) of NAEH
时间窗: At 6 months
Complete Resolution will be evaluated as benign endometrium.
次要结局
- Recurrence of NAEH after CR(At 3 months follow up after 6 months treatment)
- Progression after CR(At 3 months follow up after 6 months treatment)
- 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)