[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578152":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","PLACEBO_COMPARATOR","Group A will serve as our control group with participants on their existing gender-affirming therapy in addition to a placebo pill.\n\nLaboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","EXPERIMENTAL","Group B will serve as our intervention group with participants on their existing gender-affirming therapy in combination with 200 mg oral micronized progesterone at bedtime.\n\nLaboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.",[19],"Drug: Progesterone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo","The placebo will be nearly identical in size, color, and shape to micronized progesterone",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Progesterone","Oral micronized progesterone 200 mg",[15],[32],"Prometrium 200mg",[34],{"name":35,"affiliation":5,"role":36},"Vin Tangpricha, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","404-727-7254","vin.tangpricha@emory.edu",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":26},"Kayla Tanya Patel, MD",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Emory Transgender Clinic","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.38798,33.749,{"lat":57,"lon":56},[60],{"name":35,"role":39,"phone":61,"phoneExt":26,"email":41},"404) 727-7254",{"type":36,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Vin Tangpricha","Professor of Medicine","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":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84],"Transgender Women",[86,87,28],"Gender affirming hormone therapy","Transgender women","2025-12-22",{"date":90,"type":91},"2025-12-24","ACTUAL",{"date":93,"type":91},"2025-05-12",{"date":95,"type":78},"2027-02",{"name":5,"class":6},1]