MigraineNCT04012593
Diary-based Study on the Course of Hormone-withdrawal Migraines
An observational study of Migraine, run by University of Zurich at 1 site in Switzerland.
Trial summary
Single centered diary-based study to identify course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives Objectives of the Research Project: to identify the course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Diary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to 31 Aug 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Premenopausal women
Who may be able to join
- Premenopausal women
- Age 18-50 years
- Use of combined hormonal contraceptives 21/7 regimen
- Suffering from headache/migraine in the HFI.
- Women are allowed to use their normal headache medications
Who cannot join
- Withdrawal of consent
- incomplete diaries
- pregnancy
- migraine/headache in only 1 cycle
- inability to follow procedures (e.g. due to psychological disorders or dementia), insufficient knowledge of project language).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
Single centered diary-based study to identify course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives Objectives of the Research Project: to identify the course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives (CHC)
Read the detailed description
Participant recruitment is performed through advertisement placed in University Zürich (USZ) online. Advertisement in offices of neurologists and headache specialists, homepage of the Swiss headache society.
Interested women contact the investigators via email and are called back by one of the study doctors or students within 1 day from Monday-Friday. This phone call is thought to inform the women about the study in more detail and for the investigators to check eligibility. During this call the participants are informed about the study procedure and can ask any question. Here most important points are use of a CHC in a 21/7 regimen, regular (at least once on two months) withdrawal migraine/headaches, intention to continue the use of the contraceptive for 3 more months.
If the participants decide to participate, inclusion and exclusion criteria are checked. If women are applicable they receive the consent form and the study information with an envelope for return. If more questions come up the investigators are available per email and phone for answers. If a patient doesn't return the consent form the investigator will delete the personal data, which collected before. Only the year of birth will be noted in the personal data.
After consent participants receive headaches diaries (with mail /post) and a prepaid envelope (for return). Participants are also offered the option to return their diaries electronically via email to the study doctor. Furthermore participants receive in a second phone contact instructions, how to fill in the headache diary and the day of study start (first day of the next pill package).
Headache diaries should be returned monthly (per email or post) and are conducted for 3 pill cycles.
If complete headache diaries are not returned participants will be contacted per email after 1 week to remind the participants. If this email is not being answered within another week a phone contact will take place to identify potential reasons for noncompliance or withdrawal of consent or drop out.
Observation period 3 pill cycles : 3 times 28 days
Outcomes of the Research Project:
- Daily number of headaches and migraine in each day of the observation cycle.and during the Hormone-free interval (HFI)
- First day of migraine in the pill-free interval
- Start of migraine in relation to withdrawal bleeding
- Start of and number of prolonged migraines >24 hours in the pill-free interval and the phase of hormone intake.
- Pain intensity in the pill-free interval in comparison to the pill-phase
- Number of rescue medications/ migraine day during HFI and during pill intake
- efficacy of the medications (did medication stop the attack and did the attack return after maximal 8 hours)
- Within patient variability of the first migraine day in the HFI.
Statistical Methodology:
- Primary and secondary endpoints will be calculated as frequencies and percentages.
- For comparison the number of prolonged attacks during pill use and the HFI prolonged attacks per day of the observation interval are calculated and thereafter chi-square test for comparisons is used .
- Software programme is used for data analyses.
- Conditions
- Migraine
- Being tested
- Diary
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women | diary Receives: Behavioral: Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine in the pill-free interval
Migraine at each day of the pill-free interval
Measured: up to 3 months
Secondary outcomes (2)
First migraine day
First day of migraine in the pill-free interval
Measured: up to 3 months
migraine episodes
Start of migraines >24 hours in the pill-free interval
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study startJan 2017
- Primary completion15 Apr 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Merki, Professor, Study director, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012593
- Sponsor's protocol ID
- 2016-01791
- Other IDs
- 2016
- Status last verified
- Jul 2019
- First submitted
- 27 Sep 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
- ClinicalTrials.gov ID
- NCT04012593
- Acronym / sponsor ID
- 2016-01791
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 9 Jul 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.
Single centered diary-based study to identify course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives Objectives of the Research Project: to identify the course and characteristics of hormone withdrawal headaches/migraines in users of combined hormonal contraceptives (CHC)
Detailed description
Participant recruitment is performed through advertisement placed in University Zürich (USZ) online. Advertisement in offices of neurologists and headache specialists, homepage of the Swiss headache society.
Interested women contact the investigators via email and are called back by one of the study doctors or students within 1 day from Monday-Friday. This phone call is thought to inform the women about the study in more detail and for the investigators to check eligibility. During this call the participants are informed about the study procedure and can ask any question. Here most important points are use of a CHC in a 21/7 regimen, regular (at least once on two months) withdrawal migraine/headaches, intention to continue the use of the contraceptive for 3 more months.
If the participants decide to participate, inclusion and exclusion criteria are checked. If women are applicable they receive the consent form and the study information with an envelope for return. If more questions come up the investigators are available per email and phone for answers. If a patient doesn't return the consent form the investigator will delete the personal data, which collected before. Only the year of birth will be noted in the personal data.
After consent participants receive headaches diaries (with mail /post) and a prepaid envelope (for return). Participants are also offered the option to return their diaries electronically via email to the study doctor. Furthermore participants receive in a second phone contact instructions, how to fill in the headache diary and the day of study start (first day of the next pill package).
Headache diaries should be returned monthly (per email or post) and are conducted for 3 pill cycles.
If complete headache diaries are not returned participants will be contacted per email after 1 week to remind the participants. If this email is not being answered within another week a phone contact will take place to identify potential reasons for noncompliance or withdrawal of consent or drop out.
Observation period 3 pill cycles : 3 times 28 days
Outcomes of the Research Project:
- Daily number of headaches and migraine in each day of the observation cycle.and during the Hormone-free interval (HFI)
- First day of migraine in the pill-free interval
- Start of migraine in relation to withdrawal bleeding
- Start of and number of prolonged migraines >24 hours in the pill-free interval and the phase of hormone intake.
- Pain intensity in the pill-free interval in comparison to the pill-phase
- Number of rescue medications/ migraine day during HFI and during pill intake
- efficacy of the medications (did medication stop the attack and did the attack return after maximal 8 hours)
- Within patient variability of the first migraine day in the HFI.
Statistical Methodology:
- Primary and secondary endpoints will be calculated as frequencies and percentages.
- For comparison the number of prolonged attacks during pill use and the HFI prolonged attacks per day of the observation interval are calculated and thereafter chi-square test for comparisons is used .
- Software programme is used for data analyses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premenopausal women | – | Behavioral: Diarydiary |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Premenopausal women
Key inclusion criteria (5 listed)
- Premenopausal women
- Age 18-50 years
- Use of combined hormonal contraceptives 21/7 regimen
- Suffering from headache/migraine in the HFI.
- Women are allowed to use their normal headache medications
Key exclusion criteria (5 listed)
- Withdrawal of consent
- incomplete diaries
- pregnancy
- migraine/headache in only 1 cycle
- inability to follow procedures (e.g. due to psychological disorders or dementia), insufficient knowledge of project language).
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 |
|---|---|---|
| Diary | Behavioural | premenopausal women |
Primary outcome
Migraine in the pill-free interval
Time frame: up to 3 months
Migraine at each day of the pill-free interval
2 secondary outcomes
First migraine day
Time frame: up to 3 months
migraine episodes
Time frame: up to 3 months
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 30 Apr 2021.
- 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.
Gabriele Merki, Professor study director
University Hospital, Zürich
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 Migraine, run by University of Zurich at 1 site in Switzerland.
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 5 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 30 Apr 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 Switzerland. 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?
Migraine in the pill-free interval (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2021.