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

Endocrinological Profile in Patients With Medication-overuse Headache Before

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 Overview

• Status: Completed
• Conditions: Migraine; Medication Overuse Headache; Endocrine Disorder; Deficiency
• Intervention / Treatment: Other: Standard withdrawal therapy

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50 women.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Collaborators: Fertility Department, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache; Headache Disorders, Secondary; Endocrine System Diseases
• Other Study ID Numbers: H-19023379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No