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Completed

NCT Number: NCT04090333

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

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.

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Key information

Conditions

Endocrine Disorder Brain Diseases Central Nervous System Diseases Deficiency Endocrine System Diseases Headache Disorders Headache Disorders, Primary Headache Disorders, Secondary Medication Overuse Headache Migraine Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard withdrawal therapy

Other

All painkillers are abruptly stopped for a 2 months period.

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

    Time frame: 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 outcomes

  1. Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.

    Time frame: At baseline; and from baseline to 2 months follow-up

  2. Types and doses of analgesics, migraine medication, rescue medication and other medication during the withdrawal period.

    Time frame: At baseline; and from baseline to 2 months follow-up

  3. 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.

    Time frame: At baseline; and from baseline to 2 months follow-up

  4. 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.

    Time frame: At baseline; and from baseline to 2 months follow-up

  5. Comparison of a broad screening of the endocrinological profile before and 2 months after withdrawal.

    Time frame: At baseline; and from baseline to 2 months follow-up

  6. Relation between headache days per month and levels of hormones at baseline and at 2 months follow-up.

    Time frame: At baseline; and from baseline to 2 months follow-up

  7. Relation between reproductive health related to compensated hypogonadism, e.g. erectile dysfunction at baseline and at 2 months follow-up.

    Time frame: At baseline; and from baseline to 2 months follow-up

  8. 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

    Time frame: At baseline; and from baseline to 2 months follow-up

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Endocrinological Profile in Patients With Medication-overuse Headache Before

Acronym: ENDOMOH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2019
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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