Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+3

+ Central Nervous System Diseases

+ Migraine Disorders

From 18 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: January 2017
See protocol details

Summary

Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleSingle Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
NCT04012593
Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

47 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesMigraine DisordersNervous System DiseasesHeadache DisordersHeadache Disorders, Primary

Criteria

5 inclusion criteria required to participate
Premenopausal women

Age 18-50 years

Suffering from headache/migraine in the HFI.

Use of combined hormonal contraceptives 21/7 regimen

Show More Criteria

5 exclusion criteria prevent from participating
Withdrawal of consent

incomplete diaries

pregnancy

migraine/headache in only 1 cycle

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Universitätsspital Zürich

Zurich, SwitzerlandOpen Universitätsspital Zürich in Google Maps
CompletedOne Study Center
Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives | PatLynk