[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586224":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":12,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":12,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":12,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":12,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Endo Health GmbH","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","NO_INTERVENTION","Control group has access to care-as-usual only.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention Group","EXPERIMENTAL","The intervention group has access to the PCOS app and its functions in in addition to care-as-usual",[18],"Device: PCOS-App",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","PCOS-App","The PCOS-App helps to implement multimodal self-help measures in the daily lives of PCOS patients through various functions such as symptom diary and interactive exercises.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Teresa Götz, M.Sc.","CONTACT","+49 371 33560304","teresa@endometriose.app",[32],{"facility":5,"status":12,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Chemnitz","Saxony","09111","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],12.92922,50.8357,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},{"type":47,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100586224","app-impact-on-quality-of-life-and-symptoms-in-pcos-100586224",false,"NCT06912594","App Impact on Quality of Life and Symptoms in PCOS","Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Legal capacity\n* Resident in Germany\n* Female gender\n* Age ≥18 years up to 65 years\n* Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)\n* Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it\n* Internet access and an email address for registration, app usage, and completing questionnaires\n* Willingness to complete questionnaires online\n* Motivation to use the app regularly\n* Sufficient knowledge of the German language\n\nExclusion Criteria:\n\n* Changes in hormone therapy within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Changes in treatment with metformin within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Current treatment with medications for obesity (e.g., liraglutide, orlistat)\n* Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Pregnancy or breastfeeding\n* Current hormonal fertility treatment\n* Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and\u002For planned within the next 12 weeks\n* Current psychotherapeutic treatment\n* Previous or current access to the Endo-App or other digital health applications (DiGAs)\n* Current participation in other clinical studies\n* Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs","FEMALE","18 Years","65 Years",{"count":59,"type":60},220,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only\u002F continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.",[66],"Polycystic Ovary Syndrome (PCOS)",[68,69,70],"PCOS","Quality of Life","Digital Therapeutics","NOT_YET_RECRUITING","2025-04-02",{"date":74,"type":75},"2025-04-06","ACTUAL",{"date":72,"type":60},{"date":78,"type":60},"2025-09",{"name":5,"class":6},1]