Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-29 @ 5:55 PM
Study NCT ID:
NCT04816357
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2021-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometriosis stage', 'timeFrame': '4 years', 'description': 'endometriosis stage confirmed by laparascopy compared to the control group'}], 'secondaryOutcomes': [{'measure': 'infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations', 'timeFrame': '4 years', 'description': 's.o.'}, {'measure': 'and age of first symptoms for both conditions and age at first operation', 'timeFrame': '4 years', 'description': 's.o.'}, {'measure': 'family history with first-degree relatives,', 'timeFrame': '4 years', 'description': 's.o.'}, {'measure': '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,', 'timeFrame': '4 years', 'description': 's.o.'}, {'measure': 'response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted', 'timeFrame': '4 years', 'description': 's.o.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Migraine']}, 'referencesModule': {'references': [{'pmid': '37132337', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36897310', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women aged 18-55 years, at time of operation\n* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)\n* For the cases migraine needs to be confirmed during the interview according to the IHS criteria.\n\nExclusion Criteria:\n\n• Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)'}, 'identificationModule': {'nctId': 'NCT04816357', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Zurich University of Applied Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2021-00285'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometriosis & Migraine', 'description': '* Premenopausal women aged 18-55 years, at time of operation\n* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)\n* For the cases migraine needs to be confirmed during the interview according to the IHS criteria.', 'interventionNames': ['Other: Questionaire']}, {'label': 'Endometriosis', 'description': '* Premenopausal women aged 18-55 years, at time of operation\n* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)', 'interventionNames': ['Other: Questionaire']}], 'interventions': [{'name': 'Questionaire', 'type': 'OTHER', 'description': 'only questionaire', 'armGroupLabels': ['Endometriosis', 'Endometriosis & Migraine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zurich University of Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Hanna Dietrich', 'investigatorAffiliation': 'Zurich University of Applied Sciences'}}}}