Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of patients with pain symptoms reduction
研究概览
简要总结
clinical trial aims to evaluate efficacy of dienogest (DNG) in comparison to goserline acetate in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology.
详细描述
The study will be a clinical trial study of 12-week trial of GnRH (zoladex 3.75mg) injection once every 4 weeks and Visanne (dienogest 2mg) oral once daily for 12 weeks in patients confirmed endometriosis by laparoscopic surgery.
Pretreatment assessment, the patients will be questioned about their pelvic symptoms (dysmenorrhea, nonmenstrual pelvic pain, and deep dyspareunia) after taking full history and examination , The study will investigate and evaluate possible early, long side effects and efficacy of treatment to controlling the pain.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non pregnant women confirmed to have endometriosis by histopathology and not received any hormonal treatment yet. Also, medical treatment was the proper choice for treatment of each case.
排除标准
- •Women suspect pregnancy.
- •Breast feeding women.
- •Previous use of hormonal agents (progestin less than 6 months, danazol less than 3 month, oral contraceptive pills less than 1 month before screening).
- •Women with other gynecological pathology interfere with treatment we will use.
- •Using of corticosteroids.
- •Family history of osteoporosis.
研究组 & 干预措施
group use GnRH
GnRH (zoladex 3.75mg) injection once every 4 weeks
干预措施: Zoladex (Drug)
Group use Visanne (dienogest 2mg) oral once daily for 12 weeks
Visanne (dienogest 2mg) oral once daily for 12 weeks
干预措施: Visanne (Drug)
结局指标
主要结局
number of patients with pain symptoms reduction
时间窗: 12 week
number of patients with endometriosis-associated pain symptoms reduction
次要结局
- assessment change in pain severity(12 weeks)