[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560516":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":16,"studyPopulation":38,"armGroups":16,"interventions":39,"overallOfficials":16,"centralContacts":44,"locations":16,"responsibleParty":50,"collaborators":16,"id":54,"slug":16,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":16,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":16,"studyType":65,"phases":16,"briefSummary":66,"conditions":67,"keywords":16,"overallStatus":69,"whyStopped":16,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":16},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Airway responsiveness to methacholine","Airway responsiveness to methacholine challenge before and after initiation of HC\u002FHRT treatment reported as a dose-response-ratio defined as change in %FEV1 per μmol","30 to 14 days before initiation of HC\u002FHRT and 7-14 days and 42-56 days following initiation",[14,17,19,21,23,25,27,29,31,33],{"measure":15,"description":16,"timeFrame":12},"Changes in lung function measured as forced expiratory volume in first second (FEV1), forced vital capacity (FVC),",null,{"measure":18,"description":16,"timeFrame":12},"Change from baseline as measured by airway oscillometry (AOS)",{"measure":20,"description":16,"timeFrame":12},"Changes in airway inflammation measured as FeNO",{"measure":22,"description":16,"timeFrame":12},"Changes in blood alarmins such as blood eosinophils, interleukin 4 (IL-4), IL-5, IL-6, IL-8, IL-10, IL-13, IL-17, IL-23, IL-33, TSLP, IL-1 and Tumor Necrosis Factor alfa (TNF-alfa)",{"measure":24,"description":16,"timeFrame":12},"Medical Research Council Dyspnea Scale (MRC) will be used to evaluate subjective dyspnea. MRC will be evaluated by medical interview.",{"measure":26,"description":16,"timeFrame":12},"Changes in allergy measured as skin prick test (SPT) to common inhaled allergens",{"measure":28,"description":16,"timeFrame":12},"Changes in body composition - fat distribution",{"measure":30,"description":16,"timeFrame":12},"Changes in body composition measured as fat percent",{"measure":32,"description":16,"timeFrame":12},"Changes in body composition measured as fat mass (kg)",{"measure":34,"description":16,"timeFrame":12},"Baseline Dyspnea Index (BDI) will be used to evaluate subjective dyspnea. Will be evaluated by medical interview.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":36,"timePerspective":37,"maskingInfo":16},"COHORT","PROSPECTIVE","Participants of this study will be women aged 18 to 75 years who for any reason are about to initiate HRT\u002FHC. Further, patients must not be on any hormonal treatment at the time of initiation of hormones and must not have any gynecological or endocrinological disorder which is known to affect the ovarian cycle.",[40],{"type":41,"name":42,"description":43,"armGroupLabels":16,"otherNames":16},"DRUG","Hormonal Therapy Agent","Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause",[45],{"name":46,"role":47,"phone":48,"phoneExt":16,"email":49},"Erik SH Hansen, MD, PHD","CONTACT","38623862","erik.soeren.halvard.hansen@regionh.dk",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Erik Soren Halvard Hansen","Principal Investigator","100560516",false,"NCT06578169","Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study","Inclusion Criteria:\n\n* Women aged 18 to 75 years\n* Planning to initiate HRT\u002FHC within next 30 days\n\nExclusion Criteria:\n\n* Gynecological, endocrinological or other disease affecting the ovarian cycle\n* FEV1 \\\u003C 60% of expected or \\\u003C 1.5L\n* Current hormonal medication\n* Pregnancy","FEMALE","18 Years","75 Years",{"count":63,"type":64},300,"ESTIMATED","OBSERVATIONAL","The project aims to investigate the effect of female sex hormone treatment (both contraceptive treatment and hormone therapy during menopause) on bronchial hyperreactivity in adult women. The study is a prospective cohort study involving 300 women, examining airway responsiveness before and after the initiation of hormone treatment, whether as hormone therapy in menopause or contraceptive treatment. Participants will be recruited from general practitioners in the Capital Region of Denmark. Lung function, bronchial hyperreactivity, airway inflammation, and body composition will be assessed before and after hormone treatment. Blood samples will also be collected and stored for later analysis of inflammation markers. The study will include women aged 18 to 75 who are about to begin hormone treatment.",[68],"Asthma","NOT_YET_RECRUITING","2024-08-27",{"date":72,"type":73},"2024-08-29","ACTUAL",{"date":75,"type":64},"2024-09-01",{"date":77,"type":64},"2027-09-01",{"name":5,"class":6}]