[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632873":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":53,"armGroups":54,"interventions":49,"overallOfficials":49,"centralContacts":64,"locations":70,"responsibleParty":88,"collaborators":49,"id":90,"slug":49,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":49,"enrollmentInfo":99,"targetDuration":49,"studyType":102,"phases":49,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":109,"whyStopped":49,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Pattern of serum CGRP levels across menstrual phases","Serum CGRP levels measured during the periovulatory and perimenstrual phases and compared among females with comorbid migraine and endometriosis, migraine only, and endometriosis only.","During the first 3 menstrual cycles, up to 6 months if extension is needed",[14,18,21,25,29,32,35,39,42,46],{"measure":15,"description":16,"timeFrame":17},"Migraine frequency","Monthly headache days recorded in the headache diary.","Baseline through completion of follow-up, up to 6 months",{"measure":19,"description":20,"timeFrame":17},"Acute medication use","Number of acute medication intake days per month recorded in the headache diary.",{"measure":22,"description":23,"timeFrame":24},"Migraine-related disability","Headache Impact Test-6 (HIT-6) score in participants with migraine.","Baseline and end of study, up to 6 months",{"measure":26,"description":27,"timeFrame":28},"Menstrually related migraine features","Prevalence and clinical characteristics of menstrually related migraine based on diary data.","During follow-up, up to 6 months",{"measure":30,"description":31,"timeFrame":24},"Endometriosis-related quality of life","The short form endometriosis health profile questionnaire (EHP-5) in participants with endometriosis",{"measure":33,"description":34,"timeFrame":17},"Endometriosis-related pain symptoms","Frequency and severity of dysmenorrhea, dyspareunia, dyschezia, dysuria, and pelvic pain assessed during study visits and diaries.",{"measure":36,"description":37,"timeFrame":38},"Serum sex hormone levels","Serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, testosterone, and prolactin.","During predefined menstrual phases across follow-up, up to 6 months",{"measure":40,"description":41,"timeFrame":28},"Association between CGRP and hormonal levels","Association between serum CGRP levels and serum hormonal levels across predefined menstrual phases.",{"measure":43,"description":44,"timeFrame":45},"Genetic markers","Genotype distribution of predefined candidate polymorphisms in genes related to CGRP signaling, hormonal pathways, and endometriosis susceptibility.","Baseline",{"measure":47,"description":48,"timeFrame":45},"Epigenetic markers","DNA methylation levels in predefined candidate regulatory regions related to inflammatory and hormonal pathways.",null,{"allocation":49,"interventionModel":49,"interventionModelDescription":49,"primaryPurpose":49,"observationalModel":51,"timePerspective":52,"maskingInfo":49},"COHORT","PROSPECTIVE","Participants will be recruited from prospectively maintained clinical databases at Vall d'Hebron University Hospital (Headache Unit and Gynecology Unit) and from outpatient clinics specialized in migraine and endometriosis. The study population consists of adult females of reproductive age with a diagnosis of migraine, endometriosis, or both, who are receiving routine clinical care at a tertiary referral center.",[55,58,61],{"label":56,"type":49,"description":57,"interventionNames":49},"Migraine and Endometriosis (MIG-EDM)","Females with a diagnosis of both migraine (ICHD-3 criteria) and endometriosis (ESHRE criteria)",{"label":59,"type":49,"description":60,"interventionNames":49},"Migraine Only (MIG-O)","Females with a diagnosis of migraine (ICHD-3 criteria) and no history of endometriosis.",{"label":62,"type":49,"description":63,"interventionNames":49},"Endometriosis Only (EDM-O)","Females with a diagnosis of endometriosis (ESHRE criteria) and no history of migraine.",[65],{"name":66,"role":67,"phone":68,"phoneExt":49,"email":69},"Patricia Pozo-Rosich, Professor","CONTACT","+34 934 89 30 00","patricia.pozo@vallhebron.cat",[71],{"facility":72,"status":49,"city":73,"state":49,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Vall d'Hebron University Hospital","Barcelona","08035","Spain","ES",{"type":78,"coordinates":79},"Point",[80,81],2.15899,41.38879,{"lat":81,"lon":80},[84],{"name":85,"role":67,"phone":86,"phoneExt":49,"email":87},"Headache Unit","+34 678876997","cefalea@vallhebron.cat",{"type":89,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100632873",false,"NCT07519343","Migraine and Endometriosis: The FEMININE Study","Investigating the inFluence of EndoMetriosis IN migraINE - FEMININE Study","FEMININE","Inclusion Criteria:\n\n1. Adult females (≥18 years old).\n2. Diagnosis of migraine according to ICHD-3 criteria confirmed by a headache specialist (for MIG-O and MIG-EDM groups).\n3. Confirmed diagnosis of endometriosis based on clinical symptoms and imaging or surgical criteria according to ESHRE guidelines (for EDM-O and MIG-EDM groups).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Individuals diagnosed with secondary headache according to the ICHD-3.\n2. Individuals with a severe disease (e.g., major psychiatric disorder, severe cardiovascular conditions).\n3. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months.\n4. Pregnant or breastfeeding females.","FEMALE","18 Years",{"count":100,"type":101},150,"ESTIMATED","OBSERVATIONAL","Migraine and endometriosis are common conditions that mainly affect females of reproductive age. Both can cause significant pain and have a strong impact on the quality of life. Increasing evidence suggests that these two conditions often occur together, and that females who have both may experience more severe symptoms than those with only one of them. However, the reasons why migraine and endometriosis are linked are still not well understood.\n\nSome biological factors may help explain this connection. One of them is a molecule called calcitonin gene-related peptide (CGRP), which plays an important role in migraine and may also be involved in pain and inflammation in endometriosis. In addition, hormonal changes during the menstrual cycle, especially fluctuations in estrogen levels, may influence symptoms in both conditions. Genetic and epigenetic factors may also contribute to this association.\n\nThe main hypothesis of this study is that females who have both migraine and endometriosis have a distinct clinical and biological profile compared to females who have only migraine or only endometriosis. In particular, it is expected that differences will be observed in CGRP levels and hormonal patterns across the menstrual cycle.\n\nThe FEMININE study is a prospective observational study that will follow females over several menstrual cycles. It will include three groups: females with both migraine and endometriosis, females with migraine only, and females with endometriosis only. Participants will record their symptoms in diaries and will provide blood samples at specific times of the menstrual cycle.\n\nThe main goal of the study is to compare CGRP levels between groups. Additional goals include describing differences in symptoms, menstrual-related migraine, hormonal levels, and selected genetic and epigenetic markers.\n\nBy improving the understanding of how migraine and endometriosis are related, this study aims to support better diagnosis and more personalized care for females affected by these conditions.",[105,106],"Migraine","Endometriosis",[108],"CGRP","NOT_YET_RECRUITING","2026-04-02",{"date":112,"type":113},"2026-04-09","ACTUAL",{"date":115,"type":101},"2026-06-01",{"date":117,"type":101},"2028-06-01",{"name":5,"class":6},1]