Migraine Clinical Trial
— ENDOMOHOfficial title:
Endocrinological Profile in Patients With Medication-overuse Headache Before
NCT number | NCT04090333 |
Other study ID # | H-19023379 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2019 |
Est. completion date | October 1, 2020 |
Verified date | February 2021 |
Source | Danish Headache Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center | Glostrup | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center | Fertility Department, Rigshospitalet, Denmark |
Denmark,
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 |
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