Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- subjective assessment of pain
研究概览
简要总结
Endometriosis is a chronic inflammatory disorder leading to painful periods, pain with intercourse and infertility. The available treatment options to alleviate pain involve mainly hormonal treatments and surgery. All current hormonal treatments are effective but disrupt the normal variations in reproductive hormones which prevent ovulation, and thus pregnancy. Statins, a group of cholesterol lowering drugs, have anti-inflammatory properties which may be helpful also for the pain related to endometriosis. The investigators plan to undertake a pilot study of 10 patients with endometriosis who will take pravastatin sodium together with coQ10, which is inhibited by statins, for a period of 3 months. If this pilot study shows that the statin treatment may decrease pain symptoms in endometriosis, then the investigators plan to undertake a larger study to further investigate this matter.
详细描述
- Initial grading of pain by a Linear Analogue Scale (LAS) from 1-10
- Initial blood biochemistry including liver function test, lipid profile, creatine/BUN, creatine kinase
- 3 months of treatment with statins (Pravastatin) in a dose of 40mg daily
- Supplementation with CoQ10 (200mg) daily for 3 months
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients of reproductive age group (18-38 years) with a clinical or surgical diagnosis of endometriosis with pain symptoms
排除标准
- •use of hormonal suppression for pain control (OCP, GnRHa) within 6-months
- •history of surgery for endometriosis within 6- months
- •current renal or hepatic active disease
- •current or history of myopathic disease
- •medication that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretrovirals, other cholesterol lowering drugs)
研究组 & 干预措施
Pravastatin
Pravastatin sodium 20mg PO daily
干预措施: Pravastatin (Drug)
结局指标
主要结局
subjective assessment of pain
时间窗: 3 months
Linear analogue scale for each component of pain (dysmenorrhea; pelvic pain; dyspareunia)
次要结局
未报告次要终点
研究者
Dr. Robert F. Casper
Professor, Dept of Obstetrics and Gynecology
Toronto Centre for Advanced Reproductive Technology