Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 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 rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.
详细描述
After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 520.
Patients are randomized to 1 of 2 treatment groups. Patients will receive MA 160 mg plus rosuvastatin 10mg by mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. 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 atypic; stable disease (SD) 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 or NR. Patients with PD will be recommended for hysterectomy.
Two 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have a confirmed pathological diagnosis based upon hysteroscopy
- •Have a desire for remaining reproductive function or uterus
- •Good compliance with adjunctive treatment and follow-up
- •Abnormal blood lipid. At least meet one of the following five items:
- •Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
- •Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
- •Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
- •High-density lipoprotein cholesterol (HDL-C) < 1.03mmol/L (40mg/dL)
- •Apo-lipoprotein-A (Apo-A) < 1.0g/L
排除标准
- •Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- •Pregnancy or potential pregnancy
- •Under treatment of high-dose progestin therapy more than 1 months in recent 6 months
- •Confirmed diagnosis of any cancer in reproductive system
- •Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- •Hypersensitivity or contradiction for using MA or statins
- •Already diagnosed with hyperlipidemia and using lipid-lowering drugs
- •With other factors of reproductive dysfunction;
- •Strong request for uterine removal or other conservative treatment
- •Smoker (>15 cigarettes a day)
- •Drinker (>20 grams a day)
研究组 & 干预措施
MA + Rosuvastatin
Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months.Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded.
Due to personal reasons, it may not be possible to accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.
干预措施: Megestrol Acetate (Drug)
MA + Rosuvastatin
Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months.Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded.
Due to personal reasons, it may not be possible to accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Pathological response rate
时间窗: 12 to 16 weeks
From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.
次要结局
- Toxicity evaluation(Up to 32 weeks)
- Relapse rate(up to 2 years after the therapy for each patient)
- Pathological response duration(Up to 2 years)
- Pathological response rate(28 to 32 weeks)
- Pathological response rate classified by different blood lipid level(Up to 32 weeks)
- Pregnancy rate(up to 2 years after the therapy for each patient)
研究者
Xiaojun Chen
Principle investigator
Obstetrics & Gynecology Hospital of Fudan University