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临床试验/NCT04012593
NCT04012593已完成不适用

Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives

University of Zurich1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Migraine in the pill-free interval

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

Migraine in the pill-free interval

时间窗: up to 3 months

Migraine at each day of the pill-free interval

次要结局

  • First migraine day(up to 3 months)
  • migraine episodes(up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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