NCT03654144Unknown4 期
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- The mean pain score after receiving treatment
研究概览
简要总结
Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic adenomyosis
- •irregular menstrual bleeding and dysmenorrhea .
排除标准
- •asymptomatic patients -
- •non-lactating patient
- •not desire for pregnancy
- •no hormonal treatment more than 6 month even contraception e.g IUD
- •no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
研究组 & 干预措施
Study group
Experimental
women will receive dienogest
干预措施: Dienogest (Drug)
control group
Active Comparator
women used combined oral contraceptive pills
干预措施: Combined Oral Contraceptive (Drug)
结局指标
主要结局
The mean pain score after receiving treatment
时间窗: 6 months
assessment by visual analog scale
次要结局
未报告次要终点
研究者
asmaa mohamed hussin yousef
Principal investigator
Assiut University
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