[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"male-hypogonadism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:male-hypogonadism":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,60,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100629557","predictors-of-androgen-status-decline-in-middle-aged-men-100629557",false,"NCT07476222","Predictors of Androgen Status Decline in Middle-Aged Men","Anthropometric, Functional and Lifestyle Determinants of Decreased Testosterone Levels in Middle-Aged Men: A Population-Based Cross-Sectional Study","TESMEN","Inclusion Criteria:\n\n* Men aged 35-59 years\n* Permanent residence in the Andijan region of Uzbekistan\n* Ability to undergo anthropometric measurements and functional performance tests\n* Ability to complete study questionnaires\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Previously diagnosed hypogonadism requiring hormonal therapy\n* Current testosterone replacement therapy or other medications affecting androgen status\n* Severe cardiovascular, hepatic or renal diseases in the stage of decompensation\n* Acute infectious or inflammatory diseases at the time of examination\n* Severe psychiatric or cognitive disorders limiting participation\n* Clinically significant urological pathology\n* Inability or unwillingness to provide informed consent",true,"MALE","35 Years","59 Years",{"count":22,"type":23},600,"ESTIMATED","OBSERVATIONAL","Age-related decrease in testosterone levels in men is associated with multiple metabolic, functional and psychosocial consequences. Early identification of modifiable factors associated with decreased testosterone levels may contribute to improved prevention of androgen deficiency and related health conditions.\n\nThis population-based analytical cross-sectional observational study aims to investigate anthropometric, functional and lifestyle-related factors associated with decreased total testosterone levels in middle-aged men. Approximately 600 men aged 35-59 years residing in the Andijan region of Uzbekistan will be recruited.\n\nParticipants will undergo comprehensive assessment including anthropometric measurements, functional performance tests, standardized questionnaires and laboratory determination of serum total testosterone levels. Anthropometric variables will include body mass index, waist circumference, hip circumference, waist-to-hip ratio and waist-to-height ratio. Functional status will be assessed using hand-grip strength, five-times chair-stand test, 4-meter walk test, balance assessment and the six-minute walk test. Lifestyle-related factors including physical activity, sleep quality, dietary habits, smoking, alcohol consumption and psychoemotional status will be evaluated using validated questionnaires.\n\nThe study aims to identify determinants of decreased testosterone levels and develop a predictive model for early identification of androgen deficiency in middle-aged men.",[27,28,29,30],"Testosterone Deficiency","Androgen Deficiency","Male Hypogonadism","Late-Onset Hypogonadism",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Testosterone deficiency","Androgen deficiency","Cross-sectional study","Men's health","Sarcopenia","Waist circumference","Body mass index","Sleep quality","Physical activity","Lifestyle factors","Functional status","Anthropometric factors","Middle-aged men","Male hypogonadism","Screening model","NOT_YET_RECRUITING","2026-05-27",{"date":50,"type":51},"2026-05-29","ACTUAL",{"date":53,"type":23},"2026-06-01",{"date":55,"type":23},"2027-12-31",{"name":57,"class":58},"Andijan State Medical Institute","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"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":68,"type":23},30,"INTERVENTIONAL",[71],"PHASE2","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).",[29,27,74,75],"Testosterone Replacement Therapy","Testosterone",[77,78,79],"testosterone pharmacokinetics","testosterone pharmacodynamics","testosterone pellets","2026-03-24",{"date":82,"type":51},"2026-03-30",{"date":84,"type":23},"2026-03",{"date":86,"type":23},"2027-04",{"name":88,"class":58},"University of Sao Paulo",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":59},"100416551","relationship-of-the-microenvironment-and-male-fertility-100416551","NCT04704141","Relationship of the Microenvironment and Male Fertility","Relationship of the Gut and Genitourinary Tract Microenvironment and Male Fertility","Inclusion Criteria:\n\n* Men diagnosed with infertility who consent to participate in the study\n\nExclusion Criteria:\n\n* Prior hormone replacement therapy\n* Antibiotic use in past 6 months\n* Inability to consent for self, due to age or mental capacity\n* Infertility attributable to identifiable causes other than hypogonadism",{"count":97,"type":23},150,"Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets.\n\nThe investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million\u002FmL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status.\n\nParticipants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically \\>1 mL, and \\\u003C0.2 mL is typically used for the semen analysis. If over 1 million\u002FmL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis.\n\nSecondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.",[100,29],"Male Infertility",[102,103,104,105],"Infertility","Microenvironment","Microbiome","Seminal Fluid","2023-04-17",{"date":108,"type":51},"2023-04-20",{"date":110,"type":23},"2023-06",{"date":112,"type":23},"2026-06",{"name":114,"class":58},"University of Illinois at Chicago"]