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

NCT ID: NCT04816357

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2021-11-04

Brief Summary

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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).

Detailed Description

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Conditions

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Endometriosis Migraine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

Questionaire

Intervention Type OTHER

only questionaire

Endometriosis

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

Questionaire

Intervention Type OTHER

only questionaire

Interventions

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Questionaire

only questionaire

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zurich University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hanna Dietrich

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Dietrich H, Knobel C, Portmann L, Metzler J, Muendane A, Niggli A, Neumeier MS, Imesch P, Merki-Feld GS. Endometriosis features and dienogest tolerability in women with depression: a case-control study. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):198-204. doi: 10.1080/13625187.2023.2199899. Epub 2023 May 3.

Reference Type DERIVED
PMID: 37132337 (View on PubMed)

Neumeier MS, Pohl H, Dietrich H, Knobel C, Portmann L, Metzler J, Imesch P, Merki-Feld GS. Endometriosis Features in Women With and Without Migraine. J Womens Health (Larchmt). 2023 May;32(5):598-607. doi: 10.1089/jwh.2022.0359. Epub 2023 Mar 10.

Reference Type DERIVED
PMID: 36897310 (View on PubMed)

Other Identifiers

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2021-00285

Identifier Type: -

Identifier Source: org_study_id

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