Comparing Metformin Plus Megestrol Acetate With Megestrol Acetate Alone as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Complete response within 16 weeks of treatment
研究概览
简要总结
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
详细描述
Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.
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
- Double (Care Provider, 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
- •18-45 years old;
- •pathologically diagnosed with AEH for the first time;
- •desire to preserve their fertility;
- •no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
- •no contraindication for metformin, megestrol acetate or pregnancy;
- •no hormone or metformin treatment within 6 months before entering the trial;
- •not pregnant when participating in the trial;
- •willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.
排除标准
- •Patients who had one or more of the following conditions:
- •allergy history or contraindications for megestrol acetate or metformin;
- •pregnant when initiating the study;
- •alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
- •high risk of thrombosis;
- •recurrent AEH;
- •endometrial cancer;
- •other malignancy history.
研究组 & 干预措施
Metformin plus megestrol acetate
Metformin 1500mg per day plus megestrol acetate 160mg per day.
干预措施: Metformin plus Megestrol acetate (Drug)
Megestrol acetate
Megestrol acetate 160mg per day.
干预措施: Megestrol Acetate (Drug)
结局指标
主要结局
Complete response within 16 weeks of treatment
时间窗: 16 weeks
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
次要结局
- 2-year pregnancy rate(2 years)
- Complete response within 32 weeks of treatment(32 weeks)
- 2-year recurrence rate(2 years)
- Adverse events(32 weeks)
- 2-year live-birth rate(2 years)