Effect of Melatonin on Reduction of Pelvic Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
In two double blinded randomized controlled trials (RCT) we will study the effect of pain reduction of melatonin vs placebo in women with severe dysmenorrhea and women with endometriosis.The aim is to find an effective method for pelvic pain caused by dysmenorrhea and endometriosis.The primary outcome is reduction of pain in patients with dysmenorrhea and endometriosis respectively when treated with melatonin vs placebo. Secondary outcomes include the effect on daily life, quality of life and cognition. Sleep will also be assessed to evaluate its potential relation to quality of life and cognition.
详细描述
Two substudies will be performed. Forty women with severe dysmenorrhea will be randomized to treatment with 10 mg melatonin daily or placebo during the menstruation for 2 menstrual cycles. Another 40 women with endometriosis will be randomized to treatment with 20 mg or placebo daily during 8 weeks. Participants will report drug intake, bleeding details (duration and amount) and pain as well as possible side effects. They will also perform a test for sleep quality and cognition before and after completion of the study.
See protocol for more details
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Regular menstrual cycles,
- •Severe dysmenorrhea (NRS>6)
- •Speaks and understands Swedish
- •If other medication, those should be un-altered for the last 3 months
排除标准
- •Prior or ongoing liver or kidney disease
- •Endometriosis
- •Pregnancy
- •Endometriosis group:
- •Criteria for inclusion:
- •Endometriosis (endometriomas or diagnosis by laparoscopy)
- •Moderate to severe pain (NRS >/= 4)
- •Good general health
- •Understands and speaks Swedish
- •If any other treatment, unchanged regimen for the last 3 months
- •Signed informed consent
- •Criteria for exclusion:
- •Prior or ongoing disease in kidney or liver
- •Use of opioid analgesics
研究组 & 干预措施
Endometriosis Melatonin 20 mg
In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
干预措施: Melatonin 20 mg (Drug)
Dysmenorrhea Melatonin 10 mg
In the dysmenorrhea group: 2 capsules with 5 mg melatonin will be given in the evening for seven days consecutively during menstruation for two mentrual cycles. Compared with placebo.
干预措施: Melatonin 10 mg (Drug)
Dysmenorrhea Melatonin 10 mg
In the dysmenorrhea group: 2 capsules with 5 mg melatonin will be given in the evening for seven days consecutively during menstruation for two mentrual cycles. Compared with placebo.
干预措施: Placebo (Drug)
Endometriosis Melatonin 20 mg
In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain reduction
时间窗: 12 weeks
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
次要结局
- Cognition(12 weeks)
- Catastrophic thinking(12 weeks)
- Side effects of Melatonin(12 weeks)
- Use of analgesics(12 weeks)
- Quality of sleep(12 weeks)
- General well being(12 weeks)
- Acceptance of Melatonin(12 weeks)
研究者
Lena Marions
Associate Professor
Karolinska Institutet