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

NCT04090333 | Completed

• 1 other identifier: H-19023379
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocrine Disorder; Deficiency; Medication Overuse Headache; Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Interventions

Standard withdrawal therapy OTHER

All painkillers are abruptly stopped for a 2 months period.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (1)

• Carlsen LN, Nielsen BS, Rouw C, Petersen MR, Lindh CH, Krais AM, Westgate CSJ, Jeppesen JV, Jensen LB, Kristensen SG, Ziebe S, Jensen RH, Kristensen DM. Overuse of analgesics can affect the fertility biomarker Anti-Mullerian Hormone in females. A translational study. Cephalalgia. 2024 Nov;44(11):3331024241290530. doi: 10.1177/03331024241290530.

  PMID: 39558601 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and urine collection

MeSH Terms

Conditions

Endocrine System Diseases; Headache Disorders, Secondary; Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)