[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gender-dysphoria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gender-dysphoria":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,49,75,103,124,144,176,200,227,255,289,311,340,361,388,414,444,465,488],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100604257","evaluating-the-efficacy-of-force-modulating-tissue-bridge-device-in-preventing-hypertrophic-scars-following-gender-affirming-mastectomy-100604257",false,"NCT07147166","Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy","Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy: A Randomized Self-Controlled Trial","FMTB Brij","Inclusion Criteria:\n\n1. Age ≥ 19\n2. Undergoing double incision gender affirming mastectomy\n3. Ability to adhere to Brijjit therapy after surgery\n4. Willing to return for follow-up visits and undergo study evaluations\n\nExclusion Criteria:\n\n1. History of keloid formation\n2. Radiation therapy history\n3. Prior surgeries of the chest or breast\n4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids\n5. Active smoker\n6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)\n7. Any other condition determined by PI to preclude subject from joining study",true,"ALL","19 Years",{"count":21,"type":22},78,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS).\n\nParticipants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.",[28,29,30],"Gender Dysphoria","Mastectomy","Hypertrophic Scar",[32,33,34,35],"Gender-affirming","Gender-affirming care","Gender-affirming mastectomy","Hypertrophic scarring","RECRUITING","2026-06-02",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":40},"2025-02-03",{"date":44,"type":22},"2032-06-01",{"name":46,"class":47},"University of California, San Francisco","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100640699","brain-health-in-transgender-adults-100640699","NCT07624747","Brain Health in Transgender Adults","Cerebral Blood Flow and Neurocognitive Performance in Adults Undergoing Gender-affirming Hormone Therapy","Inclusion Criteria:\n\n* intention to undergo GAHT\n\nExclusion Criteria:\n\n* BMI greater than 40 kg\u002Fm2\n* Age greater than 45 yrs\n* Blood pressure greater than 140\u002F90 (stage II hypertension)\n* A current diagnosis of type II diabetes\n* History of traumatic brain injury\u002Fconcussion, stroke, or seizures\n* Are post-menopausal\n* Previously taken hormone therapy medications\n* Self-reported pregnancy (no pregnancy test)","18 Years","45 Years",{"count":59,"type":22},72,"OBSERVATIONAL","The purpose of this study is to test whether and how a person's brain changes in the first few months after starting gender affirming hormone therapy (GAHT). The investigators want to know if GAHT changes: 1) cerebral blood flow (CBF), 2) brain structure, connectivity, and cognitive task performance, and 3) neurocognitive function (memory, attention, executive function, processing speed). 36 male at birth and 36 female at birth participants will conduct baseline studies prior to GAHT, with a second identical set of study visits 4-6 months after GAHT begins.",[28],[64,65],"Gender-Affirming Hormone Therapy","brain health","2026-05-28",{"date":68,"type":40},"2026-06-03",{"date":70,"type":40},"2025-10-14",{"date":72,"type":22},"2028-04",{"name":74,"class":47},"University of Wisconsin, Madison",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100460245","evaluation-of-the-variation-in-quality-of-life-during-medical-transition-for-transgender-people-100460245","NCT05273112","Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.","Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.","TRANS'ITION","Inclusion Criteria:\n\n* With a diagnosis of Gender Dysphoria according to DSM5 diagnostic criteria\n* Wishing to benefit from supportive care for their transition trajectory and addressing a care system represented by the collaborating centers participating in the study,\n* Willing to comply with all study procedures and duration,\n* Understanding and able to speak French.\n\nExclusion Criteria:\n\n* Minor or adult under curatorship, under judicial protection, persons deprived of their liberty\n* Refusal to participate after clear and fair information from the study\n* Person with sexual reassignment surgery or with cross hormon therapy since two years.","75 Years",{"count":85,"type":22},400,"Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams.\n\nThe french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence\n\nSince 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.",[28],[89,28,90,91],"Transidentity","Transition","Quality of Life","NOT_YET_RECRUITING","2026-05-19",{"date":95,"type":40},"2026-05-20",{"date":97,"type":22},"2027-01",{"date":99,"type":22},"2030-04",{"name":101,"class":47},"University Hospital, Lille",13,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":48},"100534965","effects-of-cross-sex-hormone-treatment-on-cardiac-function-myocardial-and-hepatic-fat-content-100534965","NCT06245681","Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content","Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content, Its (Anti)-Atherogenic Implications and Effects on the Insulin System: a Pilot Study","Inclusion Criteria:\n\n* DSM-IV diagnosis of Gender Identity Disorder\n* age over 18 years\n\nExclusion Criteria:\n\n* age under 18 years severe neurological or internal diseases\n\n  * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones)\n  * treatment with psychotropic agents such as SSRIs\n  * any implant or stainless-steel graft\n  * abnormal values in routine laboratory screening or general physical examination\n  * current substance abuse (determined using drug screening at the screening visit)\n  * pregnancy (determined at screening visit and first MRI scan)\n  * failure to comply with the study protocol or to follow the instructions of the investigating","99 Years",{"count":112,"type":22},40,"Background: Sex hormones are believed to play an important role in the development and progression of cardiovascular disease. However, the gender gap in onset and mortality is not yet completely understood. Transsexuals undergoing hormone therapy are a promising collective for analyzing the effects of sex hormones on atherosclerosis and other cardiovascular disease. Objectives of the study: To identify gender-specific cardiovascular changes attributed to high-dose hormone therapy in male-to-female (MtF) and female-to-male(FtM) transgender using sonography and magnet resonance spectroscopy. Study design: Longitudinal cohort study. Transsexuals will undergo two 3 Tesla MRI scan sessions: 1. baseline (before hormone treatment) and 2. after 6 months of treatment. An oral glucose tolerance test (OGTT) will be performed at baseline and 6 months after treatment onset. An overall study duration of 12 months is proposed.\n\nMaterials and Methods: MRI measurements will be performed on a 3 Tesla scanner. Study population: 10 FtM, 10 male-to-female MtF transsexuals (aged 18-50), free of hormone-medication at baseline. Relevance and implications of the study: Changes in atherosclerotic risk due to hormone therapy have been studied to no definite results and so far, little is known about the effects of hormone therapy on hepatic and myocardial fatty tissue. Hence this study will provide important new data on the broad clinical aspects of sex hormones as hormone replacement therapy in particularly opposite-sex hormone therapy.",[28],"2025-09-29",{"date":117,"type":40},"2025-10-03",{"date":119,"type":40},"2017-10-20",{"date":121,"type":22},"2028-10-20",{"name":123,"class":47},"Medical University of Vienna",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":48},"100538502","gender-affirming-hormone-therapy-and-its-impact-on-myocardial-mass-and-cardiac-function-heart-liver-and-pancreatic-fat-content-100538502","NCT06291675","Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content","Long-term Observational Study to Investigate the Effect of Gender-affirming Hormone Therapy (GAHT) on Heart Function Parameters, Heart, Liver and Pancreatic Fat Content as Well as the Insulin System and the Psychological Impact of GAHT","Inclusion Criteria:\n\n* participation in our pilot study\n\n  * ongoing gender affirming hormone therapy during the last 2 years\n  * willingness and competence to sign the informed consent form.\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n\n  * non-MRI conditional implants, grafts, and\u002For devices\n  * non-MRI conditional tattoos\n  * claustrophobia\n  * current substance abuse\n  * pregnancy\n  * failure to comply with the study protocol and\u002For not following the instructions of the study team.",{"count":132,"type":22},50,"Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce.\n\nObjectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment.\n\nStudy design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment.\n\nMaterials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires.\n\nStudy population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years.\n\nRelevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study.",[28,135],"Hormone Therapy Induced Morphologic Change","2025-09-24",{"date":138,"type":40},"2025-09-26",{"date":140,"type":40},"2023-03-03",{"date":142,"type":22},"2033-03-03",{"name":123,"class":47},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":48},"100437673","phase-3-development-of-effective-opioid-sparing-techniques-for-peri-operative-pain-management-of-transgender-patients-undergoing-gender-affirming-surgeries-100437673","NCT04979338","Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries","Inclusion Criteria:\n\n* Transgender persons 18 years and older\n* Undergoing gender affirming surgeries performed by either Dr. Maurice Garcia (orchiectomy only, vaginoplasty with or without canal \\& orchiectomy, colon-vaginoplasty, \\& peritoneal vaginoplasty; Stage I phalloplasty, or stage II phalloplasty); Dr. Edward Ray (feminizing chest surgery, masculinizing chest surgery, stage I phalloplasty); Dr. Amit Gupta (orchiectomy and peritoneal vaginoplasty only); or Dr. Yosef Nasseri (colon vaginoplasty surgery)\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria above\n* Any contraindications to the study drugs.\n* Patients with neurologic deficits that preclude them from sensing pain.\n* Patients with implanted pain neuromodulator devices (e.g., neurostimulator)\n* Patients who do not speak English",{"count":151,"type":22},640,[153],"PHASE3","This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.",[28],[28,157,158,159,160,161,162,163,164,165,166],"Gender-Affirming Surgery","Peri-Operative Pain","Pain Management","Surgery Pain","Sex Reassignment Surgery","Gender Reassignment Surgery","Vaginoplasty","Phalloplasty","Quality Improvement","Opioid Use","2025-09-11",{"date":169,"type":40},"2025-09-17",{"date":171,"type":40},"2021-11-11",{"date":173,"type":22},"2026-09-30",{"name":175,"class":47},"Cedars-Sinai Medical Center",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":18,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":48},"100408293","pubertal-blockade-and-estradiol-effects-on-cardiometabolic-health-for-transitioning-youth-100408293","NCT04596592","Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth","PUBERTY","Inclusion Criteria (transgender females):\n\n* Identify as a transgender female\n* Age 13-16 years at the time of enrollment\n* If on a gonadotropin releasing hormone analogue, \\> 6 months exposure\n* Plan to start estradiol clinically in \\\u003C 4 months\n\nInclusion Criteria (cisgender males and females):\n\n* Males and females ages 13-16 years\n\nExclusion Criteria:\n\n* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures\n* Antipsychotic medication use\n* Type 1 or 2 diabetes (by medical history)\n* Polycystic ovarian syndrome (PCOS for cisgender females)\n* Hypertension (resting BP ≥ 140\u002F90 mm\u002FHg)\n* Weight\\> 400 lbs\n* On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)\n* Pregnancy (for cisgender females)","13 Years","16 Years",{"count":186,"type":22},90,"To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.",[189,28,190],"Transgenderism","Insulin Sensitivity","2025-06-05",{"date":193,"type":40},"2025-06-10",{"date":195,"type":40},"2021-02-15",{"date":197,"type":22},"2026-07-31",{"name":199,"class":47},"University of Colorado, Denver",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":206,"minAge":56,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":48},"100590585","phase-3-topical-estrogen-brief-intervention-to-improve-postoperative-experience-for-transgender-men-undergoing-hysterectomy-100590585","NCT06969326","Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy","Inclusion Criteria:\n\n1. Gender diverse\u002Ftransgender men\n2. Age 18 or older\n3. Have been on testosterone for at least 6 months with plan to undergo gender-affirming hysterectomy and are willing to be randomized to the use of topical estrogen postoperatively.\n4. Have stable physical and mental health\n5. No contraindications to estrogen therapy\n6. Must be proficient in English or Spanish\n7. Must have access to a device to receive text messages for study follow up\n8. Must agree to allow their medical data to be used for research purposes\n\nExclusion Criteria:\n\n1. Under age 18\n2. Have not been on testosterone for at least 6 months prior to planned hysterectomy\n3. Known allergy to topical estrogen","FEMALE",{"count":208,"type":22},48,[153],"The purpose of this study is to determine if applying a single dose of topical estrogen cream in the operating room at the end of your hysterectomy (removal of uterus and cervix) improves the postoperative experience with bleeding and potential symptoms of dysphoria (a feeling of discomfort or distress). Topical estrogen cream is sometimes used if patients have increased risk of bleeding with surgery but is not currently utilized in a consistent way. This study aims to answer the question of whether this is a helpful treatment and should be included in standard postoperative care.",[212,28,213],"Postoperative Bleeding","Hysterectomy",[215,216,217],"gender dysphoria","gender affirmation","hysterectomy","2025-05-08",{"date":220,"type":40},"2025-05-13",{"date":222,"type":40},"2025-05-01",{"date":224,"type":22},"2026-12-01",{"name":226,"class":47},"Women and Infants Hospital of Rhode Island",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":18,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100543102","phase-3-evaluation-of-the-effectiveness-of-hormonal-treatment-in-adolescents-suffering-from-gender-dysphoria-100543102","NCT06351501","Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering from Gender Dysphoria","TRANSADO","Inclusion Criteria:\n\n* Adolescents aged 14+\u002F- 6 months,\n* Having initiated puberty: tanner score ≥2 for FtM; tanner score ≥2 (clinic and\u002For testosterone \\>0.3 ng\u002FmL) for MtF\n* Presenting the criteria for gender dysphoria according to the DSM5 assessed by at least two child psychiatric interviews at least six months apart where the diagnosis of gender dysphoria was clinically established and that of associated autism spectrum disorder refuted and\u002For associated cognitive impairment, confirmed by specific scales (Gender Identity \u002F Gender Dysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA) and Utrecht Gender Dysphoria Scale (UGDS))\n* Whose indication for hormonal transition has been validated in a multidisciplinary consultation meeting after at least one consultation with the pediatric endocrinologist with clinical examination, blood pressure measurement, and information on hormonal treatments in the context of gender dysphoria.\n\nExclusion Criteria:\n\n* Contraindication to hormonal treatment (see paragraph 1.5)\n* Hormonal treatment needs to be adjusted (FtM patients treated with anti-coagulants or with thrombophilia).\n* Patients with risk of aggravation of certain diseases under oestrogen treatment (MtF patients with uncontrolled diabetes with HBA1C \\> 8%, patients with cholelithiasis, biliary lithiasis, systemic lupus erythematosus, severe asthma, severe arterial hypertension, severe migraines, otosclerosis, epilepsy not controlled by treatment).\n* Patients with cancer with a risk of hypercalcemia (and associated hypercalciuria), linked to bone metastases.\n* Severe cardiac, hepatic or renal failure or ischemic heart disease, due to the risk of severe complications characterized by edema, with or without congestive heart failure.\n* Uncontrolled high blood pressure.\n* Patients with epilepsy and migraine.\n* Patients with current or history of thromboembolic events.\n* Severe untreated chronic depression\n* Current anticoagulant treatment\n* Severe autism Spectrum Disorder (clinical screening, confirmed in cases of doubt by the Social Responsiveness Scale (SRS) Raw-score \\> 76, carried out as part of usual care in cases of clinical evidence,\n* Cognitive deficit (clinical screening, confirmed by an QI \\\u003C 80 on the Weschler scale (WISC V), carried out as part of the usual treatment in the event of clinical evidence.\n* Refusal to participate in the study on the part of the adolescent or one of the holders of parental authority (both holders and the adolescent must sign a written consent after receiving appropriate information).\n* No social security cover\n* Participation in other intervention research\n* Pregnancy in progress\n* Insufficient knowledge of French","162 Months","174 Months",{"count":237,"type":22},60,[153],"Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, with regard to the discrepancy felt between his or her gender identity and his or her birth sex. From the onset of puberty, most of these self-identified transgender adolescents will persist in their transgender identity and will undergo hormonal and surgical reassignment when the time comes. International best practice guidelines recommend early treatment from the start of pubertal development to block pubertal progression, with the possibility of hormonal transition by administering sex hormones of the desired sex usually around the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more referral teams are carrying out this transition from the age of 14, although no study has been published to show its benefit compared with a transition at the age of 16. In the absence of treatment, co-morbidity among adolescents suffering from gender dysphoria is very high, with anxiety-depressive states, suicidal risk and dropping out of school in the forefront. Our hypothesis is that hormonal transition started at an age closer to physiological puberty can significantly reduce this comorbidity and improve quality of life for these adolescents. This is the first therapeutic trial to be conducted in France in the transgender adolescent population, in an area where international recommendations based on the principles of Evidence Based Medicine are essentially derived from the clinical expertise of teams who have specialized in the care of transgender people for over forty years, while clinical data derived from structured research are still very scarce.\n\nThe results of this study will guide the care of transgender adolescents, allowing them, if the study is positive, to access hormonal treatments earlier and thus more quickly improve their overall functioning, anxiety-depressive symptoms and their quality of life.",[28],[28,242,243,244],"adolescents","hormonal treatment","mental health","2025-03-10",{"date":247,"type":40},"2025-03-13",{"date":249,"type":40},"2024-06-25",{"date":251,"type":22},"2031-06-24",{"name":253,"class":47},"Assistance Publique - Hôpitaux de Paris",4,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":206,"minAge":56,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":48},"100565253","sexual-functioning-after-erection-prosthesis-placement-in-post-phalloplasty-transgender-persons-100565253","NCT06639776","Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons","Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons: a Retrospective Cohort","Inclusion Criteria:\n\n* Patient and partner age ≥ 18 years.\n* Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.\n* Patients have undergone phalloplasty as a form of genital gender affirming surgery (any type of flap combination or technique is allowed).\n* Erection prosthesis placement ≥ 6 months after phalloplasty, performed at the Ghent University Hospital. Any type of prosthesis is allowed.\n* Patient has a functional erectile prosthesis at the time of the study. Number of erectile prosthesis is not relevant for inclusion.\n* Patient is Dutch, English or French speaking.\n* Voluntary signed and written consent by patient and their optional partner.\n\nExclusion Criteria:\n\n* Patient age \\< 18 years.\n* Cisgender patients treated with phalloplasty and\u002For erection prosthesis for various reasons.\n* The erection prosthesis has been explanted or the current prosthesis is nonfunctional at time of data assessment.\n* Erection prosthesis placement \\< 6 months before study start will be excluded.",{"count":263,"type":22},150,"This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty. While phalloplasty can create a neophallus, the lack of natural erectile tissue often necessitates the use of erectile aids, including internal prostheses. However, these prostheses, originally designed for cisgender men, face challenges when used in transgender patients, such as higher risks of complications, infections, and mechanical failures. Despite these issues, some studies report high patient satisfaction, though partner satisfaction rates are significantly lower. The study will use validated and non-validated questionnaires to assess satisfaction with various types of erectile prostheses, addressing the gap in understanding how these devices impact the sexual and relational functioning of both transgender men and their partners. These questionnaires will be provided to all included patients that are minimum 6 months after placement of an internal erection prosthesis and have a functional erection prosthesis in place",[189,266,267,28,268],"Erectile Dysfunction","Prosthesis Durability","Sexual Dysfunction",[270,271,164,272,273,274,275,276,277,278,279],"Gender dysphoria","Transgender","Erectile dysfunction","Sexual function","Erection prosthesis","Penile epithesis","Medical device","Penile splint","Genital reconstruction","Patient Reported Outcome Measures (PROMs)","2024-10-11",{"date":282,"type":40},"2024-10-15",{"date":284,"type":40},"2024-07-15",{"date":286,"type":22},"2025-07-31",{"name":288,"class":47},"University Hospital, Ghent",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":17,"sex":206,"minAge":56,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":48},"100565252","erectile-aid-use-in-post-phalloplasty-and-post-metoidioplasty-transgender-patients-100565252","NCT06639763","Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients","Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients: an Epidemiological Survey","AID","Inclusion Criteria:\n\n* Patient and partner age ≥ 18 years.\n* Transgender or gender non-conforming individuals (and their partners).\n* Patients have undergone phalloplasty or metoidioplasty as a form of genital gender affirming surgery.\n* ≥6 months after phalloplasty or metoidioplasty (any type of flap or technique is allowed).\n* Sexually active or has been sexually active since phalloplasty or metoidioplasty with a partner or main sexual partner.\n* Voluntarily agreed that the data may be used for an anonymized scientific study.\n\nExclusion Criteria:\n\n* Patient age \\< 18 years.\n* Cisgender patients treated with phalloplasty or metoidioplasty for various reasons.\n* \\<6 months after phalloplasty or metoidioplasty.\n* Not sexually active since phalloplasty\u002Fmetoidioplasty.\n* Patient and\u002For partner have no interest in penetrative sexual intercourse.",{"count":298,"type":22},1000,"This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Phalloplasty and metoidioplasty are gender-affirming surgeries that often require additional aids to achieve the desired sexual function, particularly for penetration. While internal erectile prostheses are common after phalloplasty, they come with high complication rates, leading some patients to opt for non-surgical aids. However, the effectiveness and comfort of these aids are not well-documented. This study aims to fill this gap by examining the types of aids transgender men use, how well these aids meet their sexual needs, and how satisfied both they and their partners are with the outcomes, providing much-needed insight for healthcare providers and patients alike.",[189,266,28,268],[270,271,164,302,272,273,278,303,304,279,274,275],"Metoidioplasty","Reconstructive urology","Erectile aid",{"date":282,"type":40},{"date":307,"type":40},"2024-07-06",{"date":309,"type":22},"2025-06-30",{"name":288,"class":47},{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":18,"minAge":317,"maxAge":318,"enrollmentInfo":319,"targetDuration":321,"studyType":60,"phases":4,"briefSummary":322,"conditions":323,"keywords":330,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":48},"100446775","prospective-observational-study-on-sebbin-silicone-gel-filled-testicular-implants-100446775","NCT05097820","Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants","Inclusion Criteria:\n\n* The patient is an adult or a child at the time of testicular implant placement.\n* The patient is a candidate to unilateral or bilateral testicular implant placement.\n* The patient has been informed of the study, has read the patient information letter and provided oral and written consent.\n* If the patient is of French nationality, he\u002Fshe must be affiliated to the French Social Security.\n\nExclusion Criteria:\n\n* The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).\n* The patient was diagnosed with one of the following pathologies:\n\nSystemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.\n\nRheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.\n\nArthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.\n\nThe patient has any other underlying condition that could delay healing.\n\n\\- Custom-designed implants are used for surgery.","0 Years","110 Years",{"count":320,"type":22},100,"2 Years","To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.",[324,325,28,326,327,328,329,267],"Testicular Cancer","Testicular Torsion","Undescended Testes","Orchitis","Testicular Agenesis","Testicular Atrophy",[331],"testicular prosthesis","2024-09-05",{"date":334,"type":40},"2024-09-19",{"date":336,"type":40},"2021-02-05",{"date":338,"type":22},"2030-12-31",{"name":288,"class":47},{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":17,"sex":206,"minAge":56,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100507143","epithesis-versus-prosthesis-in-post-phalloplasty-transgender-patients-100507143","NCT05883553","Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.","EROS","Inclusion Criteria:\n\n* Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.\n* Patients have undergone phalloplasty as a form of genital gender affirming surgery.\n* ≥ 1 year after phalloplasty (any type of flap combination is allowed), performed at the Ghent University Hospital or Amsterdam UMC.\n* ≥ 3 months after coronaplasty and having reasonably pronounced coronal ridge, as defined by the surgeons' expert opinion (This criterion is only obligatory in the eptithesis group, not in the prosthesis group).\n* Anatomic penile length and girth as defined by the surgeons' expert opinion.\n* Absence of urethral stricture or other structural problem resulting in voiding dysfunction.\n* Normal uroflowmetry and post-void residue\n* Regain of at least minimal protective sensation up to the tip of the phallus as defined by Semmes-Weinstein monofilament testing.\n* Established (primary) sexual relationship with partner who is willing to take part in the study.\n* Both patient and partner have interest in penetrative sexual intercourse.\n* Patient is unable to penetrate the partner (anal or vaginal) adequately sexually without the aid of supportive measures (condom, taping, penile sleeve, penile epithesis or any other measure defined as supportive by the investigators).\n* Fit and eligible for erection prosthesis surgery, based on the surgeons' expert opinion.\n* No history of erection prosthesis surgery.\n* No interest in or fear of prosthesis surgery making this option obsolete (This criterion is only obligatory in the eptithesis group, not in the prosthesis group)\n* Treatment naïve in the use of the Elatortm or Erektortm epithesis.\n* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.\n\nExclusion Criteria:\n\n* Cisgender patients treated with phalloplasty various reasons.\n* Post-metoidioplasty patients (metoidioplasty as step-up to performed phalloplasty is allowed).\n* Absence of coronaplasty or coronaplasty performed \\\u003C 3 months ago or coronaplasty did not leave sufficiently pronounced coronal ridge as defined by the surgeons' expert opinion (This criterion is only obligatory in the epithesis group, not in the prosthesis group)\n* Penile dimensions are not anatomic (e.g. too small or too large).\n* Underlying LUTDs requiring further investigation and\u002For treatment.\n* Inadequate protective sensation in the penis.\n* No established (sexual) partner and\u002For partner is not willing to take part in the study.\n* Patient and\u002For partner have no interest in penetrative sexual intercourse.",{"count":112,"type":22},[25],"Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required.\n\nInternal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical.\n\nExternal penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse.\n\nThe current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.",[189,266,267,28,268],[270,271,164,272,273,274,275,276,277,279,278,303],"2024-08-02",{"date":354,"type":40},"2024-08-05",{"date":356,"type":40},"2023-05-17",{"date":358,"type":22},"2025-12-31",{"name":288,"class":47},2,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":206,"minAge":56,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":48},"100549027","phase-4-effect-of-nitropaste-in-chest-masculinizing-surgery-100549027","NCT06428669","Effect of Nitropaste in Chest Masculinizing Surgery","The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial","Inclusion Criteria:\n\n* Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.\n\nExclusion Criteria:\n\n* Minor patients (younger than 18)\n* Anyone who's not getting free nipple grafting\n* Anyone who's not utilizing double incision pattern\n* Prisoners, anyone who is allergic to nitropaste\n* Anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil)\n* Anyone who's taking soluble guanylate cyclase stimulator riociguatdz",{"count":369,"type":22},256,[371],"PHASE4","Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.",[28],[375,376,377,378],"Gender affirming surgery","Chest masculinizing Surgery","Nitropaste","Wound healing","2024-06-03",{"date":381,"type":40},"2024-06-06",{"date":383,"type":40},"2022-08-15",{"date":385,"type":22},"2025-11",{"name":387,"class":47},"University of Virginia",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":360},"100549840","voice-outcome-of-glottoplasty-cricothyroid-approximation-thyroplasty-and-chondrolaryngoplasty-100549840","NCT06439290","Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty","PURPOSE 1:\n\nInclusion criteria for surgery participants:\n\n* Persons who will soon undergo surgery on the vocal folds and\u002For larynx (including glottoplasty, cricothyroid approximation, thyroplasty and\u002For thyroid chondroplasty) at UZ Gent\n* At least 18 years old\n* Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires\n\nInclusion criteria for volunteers to provide speech samples:\n\n\\- Cisgender men or women\n\nInclusion criteria for volunteer listeners for the listening experiment:\n\n* Dutch-speaking\n* Self-reported normal hearing\n\nPURPOSE 2: same as above.\n\nPURPOSE 3:\n\nInclusion criteria for the healthy participants:\n\n* At least 18 years old\n* Sufficient command of the Dutch language to complete a Dutch questionnaire\n\nExclusion criteria for the healthy participants:\n\n\\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).\n\nInclusion criteria for the pre- and postoperative MRI participants:\n\n\\- Random selection of +- 10 participants of purpose 1.\n\nExclusion criteria for the pre- and postoperative MRI participants:\n\n\\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).","70 Years",{"count":396,"type":22},290,[25],"The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.",[400,401,189,28],"Surgery","Larynx",[271,403,404,405],"Phonosurgery","Determinants","MRI","2024-05-30",{"date":379,"type":40},{"date":409,"type":40},"2024-04-10",{"date":411,"type":22},"2027-12",{"name":413,"class":47},"University Ghent",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":48},"100367468","zephyr-a-study-evaluating-surgical-outcome-after-implantation-of-the-zephyr-zsi-475-ftm-inflatable-penile-implant-in-the-neophallus-after-female-to-male-sex-reassignment-surgery-100367468","NCT04064671","ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery","ZEPHYR: A Prospective Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery","Inclusion Criteria:\n\n* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.\n* Age ≥ 18 years.\n* Female-to-male transsexual patient.\n* Implantation of Zephyr ZSI 475 FTM erectile device.\n\nExclusion Criteria:\n\n* Absence of signed written informed consent.\n* Age \\\u003C 18 years.\n* Biological males.\n* Patients opting for penile implants other than the Zephyr ZSI 475 FTM.","100 Years",{"count":320,"type":22},"This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.",[266,28],[426,427,428,429,430,431,432,433,434,435],"female-to-male","transgender","transsexual","Zephyr","erectile device","erectile implant","neophallus","phalloplasty","gender reassignment surgery","sex reassignment surgery","2024-01-29",{"date":438,"type":40},"2024-01-30",{"date":440,"type":40},"2017-09-19",{"date":442,"type":22},"2029-12",{"name":288,"class":47},{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":318,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":48},"100438760","patient-reported-outcome-on-genital-sensitivity-and-sexual-function-after-genital-gender-affirming-surgery-100438760","NCT04993469","Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery","PROGAS","Inclusion Criteria:\n\n* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations\n* Patient age ≥ 18 years\n* Transgender male, female of gender non-conforming patient with diagnosed gender dysphoria and the specific wish to undergo genital gender affirming surgery\n* Fit for operation, based on the surgeon's expert opinion\n* Patient is able and willing to attend the follow-up consultations\n\nExclusion Criteria:\n\n* Absence of signed written informed consent and thus a patient unwilling to participate.\n* Patient age \\\u003C 18 years\n* Cisgender patients\n* Patients unfit for operation\n* Patient declares that it will be impossible for him to attend the follow-up consultations",{"count":452,"type":22},200,[25],"For genital gender affirming surgery, it remains unclear to what extent genital sensitivity might be expected and what the impact of this might be on sexual functioning.",[28],[164,302,163,457],"Vulvoplasty","2023-12-21",{"date":460,"type":40},"2023-12-22",{"date":462,"type":40},"2021-05-27",{"date":338,"type":22},{"name":288,"class":47},{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":206,"minAge":56,"maxAge":110,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":484,"leadSponsor":486,"locationsCount":48},"100489168","early-mental-response---the-emre-study-100489168","NCT05649605","Early Mental Response - The EMRE Study","Early Mental Response to Hormonal Treatment in Transgender Men - The EMRE Study","EMRE","Inclusion criteria:\n\n1. Well-informed written consent to participate in the study.\n2. Transgender man given the ICD-10 diagnosis of transsexualism.\n3. A desire for complete gender-confirming hormonal treatment.\n4. Approved for Nebido treatment by a clinically responsible Endocrinologist.\n\nExclusion criteria:\n\n1. A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen Insensitivity Syndrome, Partial Androgen Insensitivity Syndrome, untreated thyroid disease, untreated hypercortisolism, etc.).\n2. A disability that prevents the patient from fully participating in the study.\n3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).\n4. Previous use of hormone preparations without a doctor's prescription.\n5. Laboratory samples significantly outside the normal reference range.\n6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.\n7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\\> 2 times the reference range.\n8. Hypersensitivity to the active substance or to any of the excipients.\n9. Ongoing pregnancy or wishes for a pregnancy in the near future.",{"count":474,"type":22},70,[25],"Primary question: Does transgender men's experience of gender incongruence improve within 6 weeks of hormonal treatment compared to placebo? Long before any bodily changes occur.\n\nSecondary question: Does transgender men´s experience of self-esteem, quality of life, sexual desire, aggression, depression\u002Fanxiety, impulsiveness, and emotional reactivity improve during 6 weeks of cross-sex hormone therapy compared to placebo? Gender dysphoria is a condition characterized by a perceived incongruence between the body and identity. For several decades this condition has been treated with cross-sex hormone therapy and surgery, among others, in order to change the body to be more congruent with the perceived gender identity. Patient satisfaction with this treatment is very high where an overwhelming majority of patients live the rest of their lives according to their perceived gender. A clinical observation, however, is that most patients experience that the congruence between the perceived gender and the assigned one improves very quickly on hormonal treatment. Long before any changes to the body have taken place. This may be partly due to relief from having finally started treatment (i.e. a psychological\u002Fsocial explanation) but an alternative (and much more likely) explanation is that the hormonal treatment directly affects the brain. Since the cause of gender dysphoria is unknown today, this study is therefore a step in trying to clarify the mechanism. In addition, it is of value to be able to demonstrate the benefits of hormonal treatment in these patients. Finally, there is a basic research motive for this study. The effect of sex hormones on the brain is very well known from a clinical perspective but all the more unknown from a research perspective. This study will contribute knowledge in this area.",[28,478,479],"Gender Identity","Gender Issues","2023-03-07",{"date":482,"type":40},"2023-03-08",{"date":480,"type":40},{"date":485,"type":22},"2026-12-30",{"name":487,"class":47},"Karolinska University Hospital",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":17,"sex":18,"minAge":496,"maxAge":4,"enrollmentInfo":497,"targetDuration":499,"studyType":60,"phases":4,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":48},"100484055","sex-hormone-overdose-and-misuse-in-chinese-transgender-and-gender-non-conforming-population-100484055","NCT05583058","Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population","Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study","HODMChina","Inclusion Criteria:\n\n* Individuals with Chinese nationality (excluding Hong Kong SAR, Macau SAR, and Taiwan).\n* Aged over 12.\n* Identify themselves as TGNCs of any subtypes, including transgender female, transgender male, genderqueer, gender non-binary, crossdresser, or other subtypes.\n* have experienced at least one month of GAHT of any regimens and frequency in the last one year, or is taking hormones during the period of the study.\n* Hormones taken include androgen, estrogen, progesterone, anti-androgen, and anti-estrogen of any chemical structures, trade names, or regimens.\n\nExclusion Criteria:\n\n* Individuals who undertake GAHT in the absence of self-consciousness due to mental disorders, or under external coercion\u002Fabuse.\n* Refuse to sign or unable to understand the informed consent.","12 Years",{"count":498,"type":22},260,"5 Years","The investigators propose to investigate the definition of hormone overdose and misuse (HODM) in Chinese transgender and gender nonconforming population (TGNCs), address the incidence of HODM in Chinese TGNC population, related factors and risks, identify the probable causes of HODM, and follow up HODM individuals to explore long-term effects.\n\nThe research questions are:\n\nQ1 What is the definition and the criteria of HODM in Chinese TGNC population? Q2 What is the prevalence of HODM in Chinese TGNC population? Q3 What factors and risks are relevant to HODM? Q4 What are the causes? Q5 What are the long-term effects of HODM in Chinese TGNC population, compared to those who enroll in regular GAHT regimens?\n\nThe investigators decide to employ a mixed-methods design to construct a full research framework on HODM. A prospective cohort study is a component of the study.\n\nThe study can be divided into four stages to address research questions. Stage I will establish a precise definition and eligibility criteria of HODM through expert panel meeting and stakeholder engagement. Subsequently, a cross-sectional study will be conducted to evaluate the rate, subtypes, and related factors of HODM in Chinese TGNCs. In Stage III, semi-structured interviews and focus groups for TGNCs who are identified as HODM will be employed to investigate the causes, motivations and personal impact factors. This stage will be divided into two phases, Stage III-a before the cross-sectional study to provide a brief picture of HODM behaviors, and Stage III-b after the cross-sectional study to draw an overall pattern. Lastly, all participants of Stage II or III who would like to participate in our follow-up will be included in prospective cohorts to assess long-term effects.\n\nAmong the stages, the cohort study is the subject of the registration. The investigators propose two cohorts in the study. Participants who are identified as HODM will be assigned to cohort 1 \\[HODM cohort\\], and those who are identified as regular GAHT use will be assigned to cohort 2 \\[non-HODM cohort\\]. Participants will be asked to report their gender-related and hormone use-related conditions, and mental health-related conditions at specific timepoints. The investigators will compare the HODM cohort to the non-HODM cohort to see if the overall incidence of adverse effects, gender-related, hormone-related, and mental health-related conditions differ in the cohorts.",[502,28],"Gender Incongruence",[504,505,28,506],"Transgender Persons","Gender Affirming Hormone Therapy","Drug Overdose","2022-10-14",{"date":509,"type":40},"2022-10-17",{"date":511,"type":22},"2022-12-15",{"date":513,"type":22},"2029-03-30",{"name":515,"class":47},"Xiamen University"]