[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600056":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":56,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT)","ACTIVE_COMPARATOR","Transgender men\u002Fnon-binary\u002Fnon-gender-conforming initiating testosterone replacement therapy",[13],"Drug: Testosterone Cypionate 50 milligrams per millileter (mg\u002FmL) Injectable Solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Cisgender Female (CGF) control group","NO_INTERVENTION","Cisgender females serving as a control group",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Testosterone Cypionate 50 milligrams per millileter (mg\u002FmL) Injectable Solution","Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care.",[9],[26],"Testosterone Replacement Therapy",[28],{"name":29,"affiliation":5,"role":30},"Antoni Duleba, MD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","619-804-4765","aduleba@health.ucsd.edu",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"Marisa Hildebrand, MPH","mchildeb@health.ucsd.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","San Diego","California","92037","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.16472,32.71571,{"lat":51,"lon":50},[54,55],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},{"type":30,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Antoni Duleba","Professor",[60,63],{"name":61,"class":62},"National Institutes of Health (NIH)","NIH",{"name":64,"class":62},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100600056","phase-4-androgen-effects-on-the-reproductive-neuroendocrine-axis-2025-version-100600056",false,"NCT07092527","Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version","Inclusion Criteria: Transgender\u002FNon-binary Group, Initiating Testosterone Group\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-35\n* Plan to initiate testosterone therapy\n* History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT\n\nInclusion Criteria: Cisgender Female Group\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-35\n* Having regular menstrual cycles (every 24-35 days)\n\nExclusion Criteria: All\n\n* Pregnant\n* Incarcerated\n* Known cognitive impairment or institutionalized\n* Hemoglobin less than 11 gm\u002Fdl at screening evaluation\n* Weight less than 110 pounds\n* BMI \\\u003C18 or \\>35\n* Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor\n* Current or recent pregnancy within two months of study enrollment\n* Current or recent breast feeding within two months of study enrollment\n* Diabetes, or renal, liver, or heart disease\n* History of oophorectomy or hysterectomy\n* History of radiation or surgery involving brain structures and\u002For pelvis\u002Fpelvic organs\n* Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, gonadotropin-releasing hormone (GnRH) antagonists, insulinomimetics, and metformin.\n* History of prior testosterone therapy",true,"FEMALE","18 Years","35 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.",[83,84],"Transgenderism","Reproductive Issues","2026-01-13",{"date":87,"type":88},"2026-01-15","ACTUAL",{"date":90,"type":88},"2025-12-05",{"date":92,"type":77},"2028-11-30",{"name":5,"class":6},1]