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出境医 / 临床实验 / Diary-based Study on the Course of Hormone-withdrawal Migraines

Diary-based Study on the Course of Hormone-withdrawal Migraines

Study Description
Brief 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 contraceptives (CHC)

Condition or disease Intervention/treatment
Migraine Behavioral: Diary

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
Actual Study Start Date : January 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : August 31, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
premenopausal women
diary
Behavioral: Diary
Outcome Measures
Primary Outcome Measures :
  1. Migraine in the pill-free interval [ Time Frame: up to 3 months ]
    Migraine at each day of the pill-free interval


Secondary Outcome Measures :
  1. First migraine day [ Time Frame: up to 3 months ]
    First day of migraine in the pill-free interval

  2. migraine episodes [ Time Frame: up to 3 months ]
    Start of migraines >24 hours in the pill-free interval


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premenopausal women
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Contacts and Locations

Locations
Layout table for location information
Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Study Director: Gabriele Merki, Professor University Hospital, Zürich
Tracking Information
First Submitted Date September 27, 2017
First Posted Date July 9, 2019
Last Update Posted Date April 30, 2021
Actual Study Start Date January 2017
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
Migraine in the pill-free interval [ Time Frame: up to 3 months ]
Migraine at each day of the pill-free interval
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2019)
  • First migraine day [ Time Frame: up to 3 months ]
    First day of migraine in the pill-free interval
  • migraine episodes [ Time Frame: up to 3 months ]
    Start of migraines >24 hours in the pill-free interval
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diary-based Study on the Course of Hormone-withdrawal Migraines
Official Title Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
Brief 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 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Premenopausal women
Condition Migraine
Intervention Behavioral: Diary
Study Groups/Cohorts premenopausal women
diary
Intervention: Behavioral: Diary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2021)
47
Original Estimated Enrollment
 (submitted: July 8, 2019)
200
Actual Study Completion Date August 31, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012593
Other Study ID Numbers 2016-01791
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Study Director: Gabriele Merki, Professor University Hospital, Zürich
PRS Account University of Zurich
Verification Date July 2019