Far Eastern Memorial Hospital
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change of severity in dysmenorrhea
研究概览
简要总结
The aim of this study is to evaluate the efficacy between dienogest and danazol.
详细描述
Objective
Women with adenomyosis or endometripsis are often suffered from dysmenorrhea or menorrhagia. Dienogest and danazol are frequently used for the treatment of endometriosis. However, there was no literature mentioned about which medication is better for the treatment of endometriosis. Thus, the aim of this study is to evaluate the efficacy between dienogest and danazol.
Methods: All consecutive women, who have endometriosis, will be randomized to receive dienogest or danazol treatment, and will assess symptoms severity, receive CA125 examination, sonographic examination at baseline, 4 weeks and 16 weeks after treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •> 20 years old
- •Have an endometriosis-related condition (including adenomyosis, adenomyoma, ovarian endometrioma, or pelvic endometriosis).
排除标准
- •Have a history of breast cancer or other cancers.
- •Patients with vascular obstruction such as stroke.
研究组 & 干预措施
Dienogest
干预措施: Dienogest (Drug)
Danazol
干预措施: Danazol (Drug)
结局指标
主要结局
The change of severity in dysmenorrhea
时间窗: 16 weeks
Between-group difference in the score of global response assessment of dysmenorrhea
次要结局
- The change of severity in urinary symptoms(16 weeks)
- The change of severity in quality of life related to urinary symptoms(16 weeks)
- The change of severity in menstrual amount(16 weeks)
研究者
Sheng-Mou Hsiao
Chief, Department of Obstetrics & Gynecology
Far Eastern Memorial Hospital