NCT01028781终止1 期
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- pain report
研究概览
简要总结
Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Histologically/laparoscopically confirmed endometriosis
- •Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months
- •VAS of 6 or more at baseline
- •Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)
- •Patients must give written informed consent.
- •Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.
排除标准
- •Pregnant and/or lactating female
- •Users of other angiogenesis inhibitors
- •Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy
- •Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months
- •Use of norethindrone acetate (Aygestin) in the prior month
- •Seizure disorder
- •Hepatitis, or any active infection (upper respiratory infection, PID, etc)
- •History of thromboembolic disease.
- •Baseline neutropenia (ANC < 1000/mm^3)
- •Any severe physical or metal illness that would interfere with the completion of the protocol
- •Illicit drug or alcohol abuse
研究组 & 干预措施
Thalidomide
Other
Thalidomide was administered and pain reports were recorded over the course of 6 months.
干预措施: Thalidomide (Drug)
结局指标
主要结局
pain report
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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