Clinical trial NCT04090333: Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy
Official title: Endocrinological Profile in Patients With Medication-overuse Headache Before
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine Disorder
Deficiency
Medication Overuse Headache
Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: Fertility Department, Rigshospitalet, Denmark
First posted: 2019-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50 women.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of levels of following circulating and excreted hormones in the pituitary-gonadal axis at baseline and after 2 months of withdrawal
timeFrame: From baseline to 2 months follow-up
Secondary outcomes:
measure: Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: Types and doses of analgesics, migraine medication, rescue medication and other medication during the withdrawal period.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: 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.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: 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.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: Comparison of a broad screening of the endocrinological profile before and 2 months after withdrawal.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: Relation between headache days per month and levels of hormones at baseline and at 2 months follow-up.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: Relation between reproductive health related to compensated hypogonadism, e.g. erectile dysfunction at baseline and at 2 months follow-up.
timeFrame: At baseline; and from baseline to 2 months follow-up
measure: 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
timeFrame: At baseline; and from baseline to 2 months follow-up
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Copenhagen
Study officials:
References: