NCT02542410已完成2 期
Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Score in Worst Pain Over the Last Month
研究概览
简要总结
The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgically confirmed endometriosis
- •Age between 15-40 y, and premenopausal
- •Pelvic pain score ≥3 on a Visual Analog Scaleover the last month
排除标准
- •Use of other concurrent hormone medications (such as birth control pills)
- •Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)
- •Pregnancy
- •Breast cancer
- •Active thromboembolic disease
- •Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders
研究组 & 干预措施
Control
Active Comparator
Norethindrone acetate 5 mg po daily x 6 months
干预措施: Norethindrone acetate (Drug)
Experimental
Experimental
cabergoline 0.5 mg PO twice weekly x 6 months
干预措施: Cabergoline (Drug)
结局指标
主要结局
Change in Score in Worst Pain Over the Last Month
时间窗: Baseline, 6 months
visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome Outcome measures is calculated as the value at 6 months minus value at baseline.
次要结局
- Changes in Pain Interference Scores(Baseline, 6 months)
研究者
Amy DiVasta, MD
Principal Investigator
Boston Children's Hospital
研究点 (1)
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