[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559924":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":70,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":22,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":22,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":54,"whyStopped":22,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral estrogen treatment","ACTIVE_COMPARATOR","Turner syndrome patients receiving oral estrogen treatment (Estrofem®)",[13],"Drug: 17-beta estradiol",{"label":15,"type":10,"description":16,"interventionNames":17},"Transdermal estrogen treatment","Turner syndrome patients receiving transdermal estrogen treatment (Divigel)",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Controls","NO_INTERVENTION","Healthy age-matched controls receiving no treatment",null,[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","17-beta estradiol","Treatment with orally administered estrogen for 6 months",[9],[30],"Estrofem",{"type":25,"name":26,"description":32,"armGroupLabels":33,"otherNames":34},"Treatment with transdermally administered estrogen for 6 months",[15],[35],"Divigel",[37],{"name":38,"affiliation":39,"role":40},"Claus H Gravholt, Professor","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Camilla M Balle, Ph.d.-student","CONTACT","40769623","0045","camibl@clin.au.dk",{"name":38,"role":44,"phone":49,"phoneExt":46,"email":50},"78455470","claus.gravholt@clin.au.dk",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Department of Endocrinology and Internal Medicine, Aarhus University Hospital","RECRUITING","Aarhus","Aarhus N","8200","Denmark","DK",{"type":61,"coordinates":62},"Point",[63,64],10.21076,56.15674,{"lat":64,"lon":63},[67],{"name":43,"role":44,"phone":45,"phoneExt":22,"email":47},{"type":69,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[71],{"name":5,"class":6},"100559924","phase-4-long-term-effects-of-oral-versus-transdermal-estrogen-replacement-therapy-in-turner-syndrome-100559924",false,"NCT06570460","Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome","Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome - A Randomized Trial","Inclusion criteria:\n\nFor participants with TS:\n\n* Diagnosis of TS regardless of karyotype\n* Age 18-50 years\n* Already receiving estrogen treatment\n\nFor healthy controls:\n\n* Female\n* Age 18-50 years\n* Previously healthy\n* Not receiving any medication\n* Not using any form of contraceptive pills\n* No mental or psychiatric disorders\n\nExclusion criteria:\n\n* Active systemic chronic diseases\n* Known or suspected breast cancer\n* Known or suspected estradiol-dependent tumors (endometrial cancer or similar)\n* Untreated endometrial hyperplasia\n* Current or previous venous thromboembolism\n* Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more\n* Known hypersensitivity to the medications used\n* Pregnancy\n* Menopause (for the control group only)",true,"FEMALE","18 Years","50 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This 14-month, phase IV, randomized controlled crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The study's objectives are to clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in TS after a wash-out period without estrogen (E2) treatment; compare the effects of oral versus transdermal (TD) ERT regimens; and examine the long-term effects of E2 administration via these two routes. The study involves 50 TS women aged 18-50 years and 50 control participants. TS participants are randomized to receive either oral or TD ERT for six months, followed by crossover to the alternate treatment for another six months. Prior to randomization, any existing ERT will be discontinued for a 1-month washout period. A second 1-month washout period will occur between the two 6-month treatment phases. Laboratory analyses and clinical investigations are performed after the first wash-out period, after the first six months of treatment, and after the last six months of treatment. We anticipate that this study may provide a basis for new and improved recommendations for sex hormone replacement therapy in TS.",[91,92,93,94,95],"Turner Syndrome","Hypogonadism; Ovarian","Hormone Replacement Therapy","Estrogen Replacement Therapy","Estrogen Deficiency",[97,98,99,100,101],"Turner syndrome","Hormone replacement therapy","Estrogen replacement therapy","Estrogen treatment","Long term side effects","2024-08-22",{"date":104,"type":105},"2024-08-26","ACTUAL",{"date":107,"type":105},"2021-11-29",{"date":109,"type":85},"2026-12-31",{"name":39,"class":6},1]