[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"testosterone-replacement-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:testosterone-replacement-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632333","phase-2-effect-of-testosterone-on-elderly-frail-men-with-testosterone-deficiency-100632333",false,"NCT07512323","Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency","Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study","Inclusion Criteria:\n\n* Men aged 70 or over.\n* Living at home in their own home or in sheltered housing.\n* Independent walking function, possibly with a walking aid.\n* Able to perform the chair-stand test a maximum of 8 times in 30 seconds or Timed Up and Go (TUG) of at least 30 seconds.\n* There must be at least 3 symptoms of frailty or objective findings.\n* Serum testosterone \\\u003C 10 nmol\u002FL as an average of 2 independent measurements at the Center for Growth and Reproduction, Rigshospitalet.\n\nExclusion Criteria:\n\n* Known or previous prostate cancer.\n* Abnormally elevated serum PSA (PSA = prostate-specific antigen) corresponding to PSA \\> 5 ng\u002Fml or PSA \\> 0.15 ng\u002Fml\u002Fcc (relative to prostate size in cubic centimeters (cc)).\n* Hemochromatosis.\n* Heart diseases in the form of: Peri-, myo-, or endocarditis, angina pectoris, severe heart failure (NYHA class III and IV), severe hypertension (systolic BP \\> 180 or diastolic BP \\> 105 mmHg after possible antihypertensive treatment). - Resting dyspnea.\n* Liver (ASAT \\> 2 x upper normal limit) or renal insufficiency (serum creatinine \\> 200 micromol\u002Fl).\n* Severe intractable epilepsy or migraine.\n* Insulin treatment.\n* Previous or current bisphosphonate, fluoride, HRT, SERM, strontium, teriparatide, or more than 3 weeks of prednisolone treatment.\n* Joint disease with acute inflammation.\n* Active cancer disease, in chemo- or radiotherapy.\n* Bone metabolic disease except for age-related osteoporosis.\n* Autoimmune diseases, chronic systemic diseases (cirrhosis, AIDS, chronic renal failure).\n* Primary testosterone deficiency in the form of testicular dysgenesis, Klinefelter syndrome (47,XXY), 46,XX males, LH resistance, Y chromosome deletions, other sex chromosome abnormalities.\n* Significant abuse, mental illness, dementia, physical handicaps with inability to complete the intervention or tests, or to give informed consent.\n* Contraindications for testosterone undecanoate are thus included in exclusion criteria, such as the presence of liver tumors, breast carcinoma, and prostate cancer, for which trial participants will be examined before the start of the trial.","MALE","70 Years",{"count":19,"type":20},96,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.",[26,27,28,29],"Frail Elderly Patients","Hypogonadal Males","Testosterone Replacement Therapy","Falls (Accidents) in Old Age",[31,32,33,34],"hypogonadism","frailty","falls","testosterone replacement therapy","NOT_YET_RECRUITING","2026-04-29",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":20},"2026-08-01",{"date":43,"type":20},"2030-09-30",{"name":45,"class":46},"Rune Skovgaard Rasmussen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100631445","phase-2-clinical-evaluation-of-subcutaneous-testosterone-implants-in-men-with-symptomatic-hypogonadism-100631445","NCT07500766","Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism","Inclusion Criteria:\n\n* Absence of desire for future fertility.\n* Two fasting total testosterone measurements ≤ 350 ng\u002FdL obtained between 6:00 and 10:00 a.m.\n* A positive ADAM questionnaire result (Participants with a prior diagnosis of testosterone deficiency established at this institution who are currently receiving testosterone replacement therapy and wish to participate in the study will be eligible for inclusion after completion of an appropriate washout period of the testosterone formulation in use.)\n\nExclusion Criteria:\n\n* Inability to complete or respond to study questionnaires.\n* Body mass index (BMI) \\> 35 kg\u002Fm².\n* Untreated depression, defined as a Beck Depression Inventory score \\> 20.\n* Personal history of cancer.\n* Suspicious findings on digital rectal examination or breast examination.\n* Prostate-specific antigen (PSA) \\> 4 ng\u002FmL.\n* History of thrombosis.\n* Known thrombophilia.\n* Erythrocytosis.\n* Polycythemia.\n* Elevated liver enzymes (AST or ALT \\> 1.5 times the upper limit of normal).\n* Untreated chronic disease.\n* Heart failure classified as New York Heart Association (NYHA) class III or IV.\n* History of cardiovascular disease within the previous 6 months.\n* Substance use disorder or alcohol dependence.\n* Use of antiandrogen medications (flutamide, bicalutamide, enzalutamide, apalutamide, spironolactone, cyproterone acetate, abiraterone, ketoconazole, dutasteride, finasteride).\n* Use of estrogenic medications (estradiol, conjugated estrogens, progestogens).\n* Use of anabolic androgenic steroids without medical indication.\n* Untreated hypothyroidism.\n* Known allergy or hypersensitivity to testosterone or any component of the implant (testosterone, stearic acid).","18 Years",{"count":56,"type":20},30,[23],"Introduction:\n\nMale hypogonadism is a clinical syndrome associated with significant consequences for health and quality of life. In Brazil, approved testosterone replacement therapy options are limited to injectable formulations and transdermal gels, which are often associated with suboptimal adherence. Subcutaneous testosterone implants, already used in the United States and recommended by international guidelines, represent a promising alternative but are not yet available in Brazil.\n\nObjective:\n\nTo evaluate the efficacy, safety, pharmacokinetics, and quality-of-life impact of 200 mg testosterone implants manufactured in Brazil for the treatment of men with symptomatic hypogonadism.\n\nMethods:\n\nThis is a prospective interventional study conducted at the Division of Urology of the Hospital das Clínicas, University of São Paulo School of Medicine (FMUSP). Thirty cisgender hypogonadal men meeting strict inclusion and exclusion criteria will be enrolled. Participants will receive subcutaneous testosterone implants totaling 800 mg and will be followed for six months. Serial blood sampling will be performed to assess hormonal levels (total and free testosterone, LH, FSH, and PSA) and metabolic parameters (lipid profile, body mass index, and waist circumference). Validated questionnaires, including the IIEF-15, ADAM, and WHOQOL-BREF, will be used to evaluate sexual function, hypogonadal symptoms, quality of life, and patient satisfaction.\n\nOutcomes:\n\nThe primary outcome is the ability of the implants to achieve and maintain therapeutic serum testosterone levels (450-800 ng\u002FdL). Secondary outcomes include pharmacokinetic profile (Cmax, half-life, and mean duration), metabolic effects, changes in quality of life, and treatment adherence.\n\nClinical Significance:\n\nThis study advances the understanding of a testosterone replacement modality that may offer greater convenience for selected patients and for which data on nationally manufactured products are currently lacking. Over a six-month period, the study will investigate laboratory behavior, clinical impact, and patient satisfaction.\n\nRelevance and Impact:\n\nThis is the first study of its kind conducted in Brazil, combining methodological rigor with a robust design to evaluate the safety and efficacy of domestically manufactured testosterone implants. The methodology incorporates detailed ethical and scientific criteria, ensuring high-quality data. The results may support regulatory and clinical decision-making, benefiting patients and potentially contributing to the Brazilian Unified Health System (SUS).",[60,61,28,62],"Male Hypogonadism","Testosterone Deficiency","Testosterone",[64,65,66],"testosterone pharmacokinetics","testosterone pharmacodynamics","testosterone pellets","2026-03-24",{"date":69,"type":39},"2026-03-30",{"date":71,"type":20},"2026-03",{"date":73,"type":20},"2027-04",{"name":75,"class":46},"University of Sao Paulo",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":54,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":97,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":47},"100570688","histological-results-in-transgender-individuals-assigned-to-females-at-birth-undergoing-gender-affirmation-surgery-and-in-testosterone-therapy-100570688","NCT06710496","HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY","Inclusion Criteria:\n\n* gender incongruence diagnosis\n* people assigned female at birth\n* age \\>18 years\n* gender affirming surgery with hysterectomy\n* testosterone therapy\n\nExclusion Criteria:\n\n* previous gynecological surgery\n* previous gynecological disorder diagnosis","FEMALE",{"count":84,"type":20},100,"OBSERVATIONAL","The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.",[88,89,28,90,91,92,93,94,95,96],"Pregnancy","Smoking Behavior","Drugs","Comorbidities and Coexisting Conditions","Gynecological Surgery","Transgender Men","Gender Affirmation Surgery","Hormone Replacement Therapy","Gynecological Disorders",[98,99,100],"transgender","afab","histology","2024-11-26",{"date":103,"type":39},"2024-11-29",{"date":105,"type":20},"2024-12",{"date":107,"type":20},"2025-12",{"name":109,"class":46},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]