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.
Study Type
OBSERVATIONAL
Enrollment
50
All painkillers are abruptly stopped for a 2 months period.
Danish Headache Center
Glostrup Municipality, Copenhagen, Denmark
Comparison of levels of following circulating and excreted hormones in the pituitary-gonadal axis at baseline and after 2 months of withdrawal
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.
Time frame: From baseline to 2 months follow-up
Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At baseline; and from baseline to 2 months follow-up
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