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

Sponsor
Zurich University of Applied Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04816357
Collaborator
(none)
344
1
7.4
46.7

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Questionaire

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
344 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
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
Actual Study Start Date :
Mar 25, 2021
Actual Primary Completion Date :
Nov 4, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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)

Other: Questionaire
only questionaire

Outcome Measures

Primary Outcome Measures

  1. Endometriosis stage [4 years]

    endometriosis stage confirmed by laparascopy compared to the control group

Secondary Outcome Measures

  1. infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations [4 years]

    s.o.

  2. and age of first symptoms for both conditions and age at first operation [4 years]

    s.o.

  3. family history with first-degree relatives, [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, [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 [4 years]

    s.o.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsspital Zürich Zürich Switzerland 8008

Sponsors and Collaborators

  • Zurich University of Applied Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanna Dietrich, Investigator, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT04816357
Other Study ID Numbers:
  • 2021-00285
First Posted:
Mar 25, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022