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

Migraine Clinical Trial

— ENDOMOH  

Official title:

Endocrinological Profile in Patients With Medication-overuse Headache Before

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090333
• Other study ID #: H-19023379
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficiency
• Endocrine Disorder
• Endocrine System Diseases
• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache
• Migraine

Intervention

Other:
• Standard withdrawal therapy
All painkillers are abruptly stopped for a 2 months period.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	Fertility Department, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 2 months follow-up
Secondary	Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.		At baseline; and from baseline to 2 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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