Diary-based Study on the Course of Hormone-withdrawal Migraines
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

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.
    

Intervention name(s): Diary
Intervention type(s): Behavioral
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premenopausal women