[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543559":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":39,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":10,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":54,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Daily oral micronized progesterone",null,"On estrogen replacement therapy using 100mg oral daily micronized progesterone",{"label":13,"type":10,"description":14,"interventionNames":10},"Etonogestrel implant (Nexplanon)","On estrogen replacement therapy with etonogestrel implant in place",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Julie C Friedman, MD","CONTACT","720-777-2667","julie.friedman@cuanschutz.edu",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Childrens Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-104.83192,39.72943,{"lat":34,"lon":33},[37],{"name":38,"role":18,"phone":19,"phoneExt":10,"email":20},"Julie Friedman, MD",{"type":40,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100543559","assessment-of-endometrial-thickness-among-adolescent-and-young-adult-patients-on-estrogen-replacement-therapy-using-daily-oral-micronized-progesterone-versus-the-etonogestrel-implant-100543559",false,"NCT06357442","Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.","Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Continuous Oral Micronized Progesterone Versus the Etonogestrel Implant: a Prospective Pilot Study","Inclusion Criteria:\n\n* Age 12-25 years at baseline\n* Female assigned at birth, with uterus\n* Diagnosis of primary ovarian insufficiency or hypogonadotropic hypogonadism, requiring estrogen replacement therapy\n* Receiving estradiol therapy-oral (1-2mg) or transdermal (0.05-0.1mg)-for at least 3 months\n* Never used progesterone therapy or discontinued progesterone therapy at least 90-days prior to enrollment\n* Consents to initiating progesterone therapy\n\nExclusion Criteria:\n\n* Uterine abnormality (e.g., Müllerian Anomaly, uterine fibroids)\n* Inability to characterize the endometrial lining on ultrasound\n* History of chemotherapy or radiation therapy\n* Inability to complete study questionnaire","FEMALE","12 Years","25 Years",{"count":52,"type":53},34,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.\n\nThe main questions it aims to answer are:\n\nAim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy\n\nAim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone\n\nAim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone\n\nParticipants will be asked to:\n\n* Get two pelvic ultrasounds\n* Fill out two surveys\n* Continue their current hormone replacement therapy\n* Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)\n\nResearchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.",[58,59,60],"Primary Ovarian Insufficiency","Hypogonadotropic Hypogonadism","Hormone Replacement Therapy",[62,63,64,65,66],"hormone replacement therapy","hypogonadism","primary ovarian insufficiency","endometrial protection","progesterone replacement therapy","2024-12-03",{"date":69,"type":70},"2024-12-06","ACTUAL",{"date":72,"type":70},"2024-07-01",{"date":74,"type":53},"2026-07-01",{"name":5,"class":6},1]