NCT00675779Unknown不适用
Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial
Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- pain relief
研究概览
简要总结
The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in 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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed written consent
- •premenopausal women aged 18-45
- •clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
- •pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale [1981])
- •no clinical signs of sexually transmitted disease
排除标准
- •cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
- •pregnancy or lactation
- •unexplained uterine/cervical bleeding
- •hormonal therapy within last 3 months (for GnRH analogs 6 months)
- •irregular menses (> 35 days) or secondary amenorrhoea (>3 months)
- •other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
- •sexually transmitted disease (gonorrhoea, Chlamydia)
- •uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
- •chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
研究组 & 干预措施
2
Experimental
oral contraceptive + atorvastatin
干预措施: atorvastatin + oral contraceptive (Drug)
1
Active Comparator
oral contraceptive
干预措施: oral contraceptive (Mercilon) (Drug)
结局指标
主要结局
pain relief
时间窗: 3,6,12 months
次要结局
- inflammatory status(6 months)
研究者
研究点 (1)
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