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

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ClinicalTrials.gov Identifier: NCT04090333
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Fertility Department, Rigshospitalet, Denmark
Information provided by (Responsible Party):
Louise Carlsen, 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.


Condition or disease Intervention/treatment
Endocrine Disorder Deficiency Medication Overuse Headache Migraine Other: Standard withdrawal therapy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endocrinological Profile in Patients With Medication-overuse Headache Before
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood samples and urine collection


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50 women.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090333


Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Louise Ninett Carlsen, Phd-student    +4538633553    louise.ninett.carlsen@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Fertility Department, Rigshospitalet, Denmark

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Responsible Party: Louise Carlsen, MD, PhD-student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04090333     History of Changes
Other Study ID Numbers: H-19023379
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Headache
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases