Metformin for the Treatment of Endometrial Hyperplasia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.
详细描述
This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18-75 years old
- •Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
- •Have no contraindications to short-term metformin therapy
- •Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula
- •Have normal serum transaminase values (AST and ALT)
- •Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy
排除标准
- •Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
- •Have a history of liver or renal dysfunction.
- •Have a random glucose of ≤ 65 or ≥ 200
- •Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.
- •Have a history of vitamin B12 deficiency
- •Are pregnant
- •Are currently taking insulin
- •Are taking a drug that may significantly interact or influence the metabolism of metformin
- •In the opinion of the investigator, the patient is felt not to be appropriate for the study
研究组 & 干预措施
Metformin
Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12).
干预措施: Metformin (Drug)
结局指标
主要结局
Response Rate
时间窗: 12 weeks
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
次要结局
- Patient Compliance(12 weeks)
- Toxicity evaluation(12 weeks)
- Potential molecular markers in response to treatment with Metformin(12 weeks)