Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Regression rate of endometrial polyps
研究概览
简要总结
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
详细描述
Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women of childbearing age from 20 to 50 years old
- •with or without menstrual changes:
- •menostaxis (longer than 7 days)
- •shortened menstrual cycles(less than 23 days)
- •menorrhagia(more than twice as much as usual)
- •abnormal vaginal bleeding(non-menstrual vaginal bleeding)
- •with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):
- •typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen;
- •atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness >1cm;
排除标准
- •no menses within half a year;
- •surgery or drug treatment of endometrial lesions in the past half year;
- •with current intrauterine device;
- •combined with other acute gynecological inflammation;
- •with clinically suspected malignant tumors;
- •long-term use of oral contraceptives;
- •with abnormal liver and kidney function;
- •with benign or malignant breast tumors;
- •with any systemic malignant tumor or a history of tumors;
- •participants who are pregnant.
研究组 & 干预措施
cohort for treatment
Participants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months.
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
Regression rate of endometrial polyps
时间窗: three months after the starting of treatment
No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
Relapse rate of endometrial polyps
时间窗: six months after the starting of treatment
Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment
次要结局
- Side effects(three months after the starting of treatment)
研究者
shuwang
Associate Professor
Peking Union Medical College Hospital