Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy

Completed

• Conditions: Deficiency; Endocrine Disorder; Medication Overuse Headache; Migraine

• Registration Number: NCT04090333
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark