Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pathological cumulative complete response rate;
研究概览
简要总结
To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
详细描述
After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770.
Patients will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 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 hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR. Patients with PD will be recommended for hysterectomy.
For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.
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
- 17 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion:
- •Untreated patients;
- •Patients with persistent lesions after one course (12 weeks) of progesterone therapy;
- •Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
- •No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
- •Have a desire for remaining reproductive function or uterus
- •Good compliance with adjunctive treatment and follow-up
排除标准
- •Hypersensitivity or contradiction for using MPA or atorvastatin
- •Pregnancy or potential pregnancy
- •Confirmed diagnosis of any cancer in reproductive system
- •Already diagnosed with hyperlipidemia and using lipid-lowering drugs
- •Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- •Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- •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
Experimental group
MPA + Atorvastatin
干预措施: Medroxyprogesterone acetate + Atorvastatin (Drug)
结局指标
主要结局
Pathological cumulative complete response rate;
时间窗: assessed up to 4 months
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
次要结局
- Relapse rate(up to 15 months after the end of treatment)
- The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue(assessed up to 4 months)
- Overall complete response rate(up to 2 years)
- Pathological response rate classified by different blood lipid level(up to 2 years;)
- Toxic Side Effect(up to 3 months after the end of treatment)
- Pathological cumulative complete response rate;(assessed up to 8 months)
- Pregnancy rate(up to 15 months after the end of treatment)
研究者
Wang Jianliu
Professor, Doctoral supervisor, Chief physician, Vice President
Peking University People's Hospital