Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System:Single Arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2006)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) in endometrial hyperplasia (EH) patients. The LNG-IUS is known as an alternative of oral progesterone agents without incurring the disadvantages of oral progestogens. Therefore, it is hypothesized that if the therapeutic efficacy of LNG-IUS is similar or above oral progesterone, LNG-IUS would be a standard treatment for the EH patients who don't want hysterectomy. LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
详细描述
PURPOSE This prospective study aims to analyze the treatment efficacy of LNG-IUS in endometrial hyperplasia patients and to analyze the accuracy of office endometrial aspiration biopsy during the LNG-IUS is placed in uterus.
ENDPOINTS The primary endpoints of this study is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW This study is a single arm, prospective multi-institutional study. Its protocol was approved by the Institutional Review Board of each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD Patient Selection and Enrollment: 12month after IRB approval of clinical trial Institution.
TREATMENT METHODS LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients with LNG-IUS inside in uterus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are histological confirmed as endometrial hyperplasia
- •Patients who don't want hysterectomy
- •Patients signed the written informed consent voluntarily
排除标准
- •Pregnancy or suspicion of pregnancy
- •Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
- •Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- •Genital (vaginal, uterine or ovarian) infection
- •Acute liver disease or liver tumor (benign or malignant)
- •Thrombosis or phlebothrombosis requiring treatment
- •Acute severe disease of arteries such as stroke or heart infarction or a history of artery disease
- •Hypersensitivity to any component of this product
结局指标
主要结局
response rate
时间窗: 12 months after LNG-IUS insertion
LNG-IUS is inserted into uterus of which patients are histologically confirmed as endometrial hyperplasia. Office endometrial aspiration biopsy and transvaginal ultrasound is conducted every 3 months at outpatients with LNG-IUS inside in uterus. At the first year of LNG-IUS insertion, D\&C is performed under anesthesia after the endometrial aspiration biopsy with LNG-IUS inside in uterus and the biopsy findings are compared. If the office endometrial aspiration biopsy shows exacerbation, treatment with LNG-IUS must be stopped and other specific treatment should be initiated.
次要结局
- consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.(3,6,9,12 months after LNG-IUS insertion)