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

NCT ID: NCT04090333

Last Updated: 2021-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endocrine Disorder Deficiency Medication Overuse Headache Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard withdrawal therapy

All painkillers are abruptly stopped for a 2 months period.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fertility Department, Rigshospitalet, Denmark

UNKNOWN

Sponsor Role collaborator

Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Louise Carlsen

MD, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 39558601 (View on PubMed)

Other Identifiers

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H-19023379

Identifier Type: -

Identifier Source: org_study_id

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