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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816357
• Other study ID #: 2021-00285
• Status: Completed
• Start date: March 25, 2021
• Est. completion date: November 4, 2021

Study information

• Verified date: February 2022
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis
• Migraine
• Migraine Disorders

Intervention

Other:
• Questionaire
only questionaire

Locations

Country	Name	City	State
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometriosis stage	endometriosis stage confirmed by laparascopy compared to the control group	4 years
Secondary	infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations	s.o.	4 years
Secondary	and age of first symptoms for both conditions and age at first operation	s.o.	4 years
Secondary	family history with first-degree relatives,	s.o.	4 years
Secondary	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.	4 years
Secondary	response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted	s.o.	4 years