Endocrinological Profile in Patients With Medication-overuse Headache Before
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of levels of following circulating and excreted hormones in the pituitary-gonadal axis at baseline and after 2 months of withdrawal
研究概览
简要总结
The project will be conducted to investigate the hormonal homeostasis in men and women, with a special emphasis on sex hormones in men and AMH level in women, before and after withdrawal of the overused analgesics among MOH patients. Additionally, a more broad endocrine profile will be explored before and after withdrawal.
It is hypothesized that patients with MOH have disturbed hormone levels, which is normalized after withdrawal of the medication-overuse.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed MOH diagnosis according to the ICHD-III (1).
- •Capable of completing headache diary and headache calendar
- •Age 18-60 years old for men and 18-50 years old for women
- •Signed informed consent
- •BMI 19-30
排除标准
- •Severe physical illness
- •Severe psychiatric disorders requiring pharmacological treatment
- •Addiction to alcohol or other drugs
- •Pregnancy or breastfeeding
- •Menopause, either natural or surgical (only women)
- •Inability to provide reliable information about medical history
结局指标
主要结局
Comparison of levels of following circulating and excreted hormones in the pituitary-gonadal axis at baseline and after 2 months of withdrawal
时间窗: From baseline to 2 months follow-up
For male patients with MOH: LH, FSH, testosterone, ratio free testosterone/LH, E2, AMH, inhibin B and sex hormone-binding globulin (SHBG) For female patients with MOH: AMH Standardized reference values are available for all the mentioned levels of sex hormones.
次要结局
- Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.(At baseline; and from baseline to 2 months follow-up)
- Types and doses of analgesics, migraine medication, rescue medication and other medication during the withdrawal period.(At baseline; and from baseline to 2 months follow-up)
- Relation between reproductive health related to compensated hypogonadism, e.g. erectile dysfunction at baseline and at 2 months follow-up.(At baseline; and from baseline to 2 months follow-up)
- Relation between PSS, HADS, and FSMC, respectively, and levels of sex hormones at baseline and at 2 months follow-up, since hormone levels may be affected in stressed periods(At baseline; and from baseline to 2 months follow-up)
- Levels of circulating pharmaceuticals at baseline and 2 months after withdrawal with special focus on paracetamol, NSAIDs, triptans and opioids for relation to levels of hormones from both genders.(At baseline; and from baseline to 2 months follow-up)
- Levels of circulating pharmaceutical metabolites (known and potential new unknown) of pa-racetamol, NSAIDs, triptans and opioids at baseline and 2 months after withdrawal with special focus for relation to levels of hormones from both genders.(At baseline; and from baseline to 2 months follow-up)
- Comparison of a broad screening of the endocrinological profile before and 2 months after withdrawal.(At baseline; and from baseline to 2 months follow-up)
- Relation between headache days per month and levels of hormones at baseline and at 2 months follow-up.(At baseline; and from baseline to 2 months follow-up)
研究者
Louise Carlsen
MD, PhD-student
Danish Headache Center