Endocrine DisorderENDOMOHNCT04090333
Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy
An observational study of Endocrine Disorder and Deficiency, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Endocrine Disorder, Deficiency, Medication Overuse Headache
- What is being tested?
- Standard withdrawal therapy
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50 women.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endocrinological Profile in Patients With Medication-overuse Headache Before
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
- Being tested
- Standard withdrawal therapy
- Medical subject headings
- Endocrine System Diseases, Headache Disorders, Secondary, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard withdrawal therapyOther
All painkillers are abruptly stopped for a 2 months period.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 2 months follow-up
Secondary outcomes (8)
Days with analgesics, migraine medication, rescue medication and other medication during the withdrawal period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline; and from baseline to 2 months follow-up
Relation between headache days per month and levels of hormones at baseline and at 2 months follow-up.
Measured: At baseline; and from baseline to 2 months follow-up
Relation between reproductive health related to compensated hypogonadism, e.g. erectile dysfunction at baseline and at 2 months follow-up.
Measured: At baseline; and from baseline to 2 months follow-up
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
Measured: At baseline; and from baseline to 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Louise Carlsen, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090333
- Sponsor's protocol ID
- H-19023379
- Acronym
- ENDOMOH
- Status last verified
- Feb 2021
- First submitted
- 12 Sep 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39558601
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrinological Profile in Patients With Medication-overuse Headache Before
- ClinicalTrials.gov ID
- NCT04090333
- Acronym / sponsor ID
- ENDOMOH / H-19023379
- Conditions
- Endocrine Disorder, Deficiency, Medication Overuse Headache, Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients fulfilling the ICHD3-criteria for medication-overuse headache. 50 men and 50 women.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard withdrawal therapyAll painkillers are abruptly stopped for a 2 months period. | Other | – |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 39558601Carlsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disorder and Deficiency, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04090333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.