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CompletedNCT04816357Updated Feb 24, 2022

Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study

An observational study in Endometriosis and Migraine, sponsored by Zurich University of Applied Sciences. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Zurich University of Applied Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
344
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation.

Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted as well as response to Dienogest treatment.

In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).

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Conditions studied

  • Endometriosis
  • Migraine
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In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 344 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Zurich University of Applied Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

From our database of operated endometriosis patients ranging from 2016-2020 100 women will be identified within the first phone call as cases with endometriosis and migraine and the threefold number (n=300) as control with endometriosis only.

Inclusion criteria

  • Premenopausal women aged 18-55 years, at time of operation
  • Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
  • For the cases migraine needs to be confirmed during the interview according to the IHS criteria.

Exclusion criteria

Exclusion Criteria:

  • Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
344 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Endometriosis & Migraine

    * Premenopausal women aged 18-55 years, at time of operation * Endometriosis confirmed with surgery and histologic staging (Report of the surgery available) * For the cases migraine needs to be confirmed during the interview according to the IHS criteria.

    Other: Questionaire

  • Endometriosis

    * Premenopausal women aged 18-55 years, at time of operation * Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)

    Other: Questionaire

Interventions

  • OtherQuestionaire

    only questionaire

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What researchers measure

Primary outcomes

  1. Endometriosis stage

    endometriosis stage confirmed by laparascopy compared to the control group

    Time frame: 4 years

Secondary outcomes

  1. infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations

    s.o.

    Time frame: 4 years

  2. and age of first symptoms for both conditions and age at first operation

    s.o.

    Time frame: 4 years

  3. family history with first-degree relatives,

    s.o.

    Time frame: 4 years

  4. Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response,

    s.o.

    Time frame: 4 years

  5. response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted

    s.o.

    Time frame: 4 years

07

Study locations

1 site
  • Universitätsspital Zürich
    Zürich, 8008, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04816357
Lead sponsor
Zurich University of Applied Sciences
Responsible party
Hanna Dietrich (Investigator, Zurich University of Applied Sciences) — Principal investigator
First posted
Mar 25, 2021
Start date
Mar 25, 2021
Primary completion
Nov 4, 2021
Completion
Nov 4, 2021
Last update
Feb 24, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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