Deficiency, Endocrine Disorder, Medication Overuse Headache, Migraine
Conditions
Brief summary
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.
Interventions
OTHERStandard withdrawal therapy
All painkillers are abruptly stopped for a 2 months period.
Sponsors
Fertility Department, Rigshospitalet, Denmark
Danish Headache Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of levels of following circulating and excreted hormones in the pituitary-gonadal axis at baseline and after 2 months of withdrawal | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period. | 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 |
| 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 |
| 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 |
Countries
Denmark
Outcome results
None listed