Megestrol Acetate Plus LNG-IUS to Megestrol Acetate or LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pathological response rate
研究概览
简要总结
To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.
详细描述
After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.
Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR, NR or PD.
After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon hysteroscopy
- •Have a desire for remaining reproductive function or uterus
- •Need to be able to undergo correlative treatment and follow-up
排除标准
- •Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- •Pregnancy or suspicion of pregnancy
- •Have a history of EAH and have disease relapse during Merina insertion
- •Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
- •Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- •Confirmed diagnosis of malignant tumor in genital system
- •Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- •Hypersensitivity or contradiction to any component of this product
- •Ask for removal of the uterus or other conservative treatment
- •Smoker(>15 cigarettes a day)
研究组 & 干预措施
MA
Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
干预措施: Megestrol Acetate (Drug)
LNG-IUS
Patients will receive LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
干预措施: Levonorgestrel-releasing Intrauterine System(LNG-IUS) (Device)
MA+LNG-IUS
Patients will receive MA (160mg po qd) plus LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
干预措施: Megestrol Acetate (Drug)
MA+LNG-IUS
Patients will receive MA (160mg po qd) plus LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
干预措施: Levonorgestrel-releasing Intrauterine System(LNG-IUS) (Device)
结局指标
主要结局
Pathological response rate
时间窗: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
the proportion of histologic regression from endometrial atypical hyperplasia to benign endometrium
Pathological response time
时间窗: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
time of histologic regression from endometrial atypical hyperplasia to benign endometrium
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 2 years after the treatment for each patient)
- Rate of relapse(up to 2 years after the treatment for each patient)
- Rate of pregnancy(up to 2 years after the treatment for each patient)
- Compliance(up to 2 years after the treatment for each patient)
研究者
Xiaojun Chen
Principal Investigator
Obstetrics & Gynecology Hospital of Fudan University