NCT04012593

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

April 30, 2021

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

September 27, 2017

Last Update Submit

April 29, 2021

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Migraine in the pill-free interval

    Migraine at each day of the pill-free interval

    up to 3 months

Secondary Outcomes (2)

  • First migraine day

    up to 3 months

  • migraine episodes

    up to 3 months

Study Arms (1)

premenopausal women

diary

Behavioral: Diary

Interventions

DiaryBEHAVIORAL
premenopausal women

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Premenopausal women

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gabriele Merki, Professor

    University Hospital, Zürich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

July 9, 2019

Study Start

January 1, 2017

Primary Completion

April 15, 2019

Study Completion

August 31, 2019

Last Updated

April 30, 2021

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)