[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transgender-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transgender-women":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100578152","phase-2-progesterone-in-gender-affirming-hormone-therapy-study-100578152",false,"NCT06807580","Progesterone in Gender Affirming Hormone Therapy Study","Effects of Oral Progesterone in Transgender Women on Breast Development, Sleep Quality, Psychological Distress, and Cardiovascular Risk","Inclusion Criteria:\n\n\\- Participants will be transgender women, who have been on gender-affirming hormone therapy for at least 6 months before the start of the study.\n\nExclusion Criteria:\n\n* Peanut allergy\n* Liver disease (liver enzyme elevations and\u002For evidence of acute or chronic hepatitis). In our lab, the upper limit of normal for aspartate aminotransferase (AST) is 39, and the upper limit of normal for alanine aminotransferase (ALT) is 52.\n* Stage 4\u002F5 chronic kidney disease\n* Congestive heart failure\n* Medical disease or medication use associated with gynecomastia (i.e tumor, hyperthyroidism, chronic kidney disease, cirrhosis, ACE inhibitors, statins, haloperidol, tricyclic antidepressants, atypical antipsychotics)\n* Pre-existing cardiovascular disease\n* Prior or current history of thromboembolism, known clotting disorders, current or recent anti-thrombotic therapy for venous thromboembolism.\n* History of breast cancer\n* Prior progesterone use\n* Uncontrolled depression and\u002For suicidal ideation\n* Current hypothyroidism (even if controlled with treatment) Progesterone in Gender Affirming Hormone Therapy 9 Version #4, 10\u002F30\u002F24\n* Cannabis use of greater than 1 use\u002Fweek in the past 3 months\n* Previously identified BRCA 1 or 2 gene mutation or other familial breast cancer.\n* Abnormal mammogram (if indicated - for patients above the age of 50 and on estrogen for 5 or more years OR positive family history of breast cancer) with results of BIRADS 3 or higher. Subjects with a BIRADS 0 mammogram must have undergone additional imaging demonstrating BIRADS 1 or 2 prior to enrollment.\n* Have had or are planning to undergo breast enhancement or gender affirming top surgery in the next 6 months\n* Uncontrolled hypertension, defined as systolic blood pressure ≥ 140 mm Hg and\u002For diastolic blood pressure ≥ 90 mmHg.\n* Triglycerides ≥ 500 mg\u002FdL.\n* In our lab, the upper limit of normal for aspartate aminotransferase (AST) is 39, and the upper limit of normal for alanine aminotransferase (ALT) is 52.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2.\n* Estradiol levels outside the stable range (100-300 pg\u002FmL)\n* Heavy smoking, defined as 25+ cigarettes per day\n* Non-English speaking or those with limited English proficiency",true,"MALE","18 Years","60 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study aims to study the effects of Oral Progesterone in Transgender Women. The primary goal is to study the effect of progesterone on psychological distress and secondarily on sleep quality, breast size, quality of life and gender congruence and cardiovascular risk.",[28],"Transgender Women",[30,31,32],"Gender affirming hormone therapy","Transgender women","Progesterone","RECRUITING","2025-12-22",{"date":36,"type":37},"2025-12-24","ACTUAL",{"date":39,"type":37},"2025-05-12",{"date":41,"type":22},"2027-02",{"name":43,"class":44},"Emory University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100531676","economic-navigation-and-strengthening-to-research-unrestricted-services-for-transgender-women-entrust-100531676","NCT06202898","Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)","Inclusion Criteria:\n\n* Aged ≥18 years\n* Male at birth\n* Identify as a woman\u002Ftransgender woman\n* Should not be consistently using PrEP (less than four doses per week)\n* Should not have any known allergy or adverse reaction to PrEP or the active drug tenofovir in ART. One of the goals of the study is to move more people into a PrEP program\n* Be able to speak and understand spoken English and\u002For Spanish (including persons who cannot read or write)\n* Have a smart phone that can take pictures\n\nExclusion Criteria:\n\n* Unwilling to adhere to study procedures\n* Participation in an HIV vaccine trial\n* Have a life-threatening SUD\\*\n* Any condition, that in the opinion of the study staff, would make participation in the study unsafe, or interfere with achieving the study objective such as medical conditions which prevents the use of PrEP\n* Unable to provide consent",{"count":53,"type":22},110,[55],"NA","The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.",[28,58,59],"Aids","Hiv","2024-12-03",{"date":62,"type":37},"2024-12-06",{"date":64,"type":37},"2023-07-11",{"date":66,"type":22},"2027-06",{"name":68,"class":44},"University of Central Florida"]