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OpenTrials
Completed

NCT Number: NCT04816357

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

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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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Questionaire

Other

only questionaire

Primary outcomes

  1. Endometriosis stage

    Time frame: 4 years

    endometriosis stage confirmed by laparascopy compared to the control group

Secondary outcomes

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

    Time frame: 4 years

    s.o.

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

    Time frame: 4 years

    s.o.

  3. family history with first-degree relatives,

    Time frame: 4 years

    s.o.

  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,

    Time frame: 4 years

    s.o.

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

    Time frame: 4 years

    s.o.

Sponsors and collaborators

Lead sponsor

Zurich University of Applied Sciences

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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