[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"testosterone-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:testosterone-deficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,60,89,118,148,179,204,230,297],{"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":95,"eligibilityCriteria":96,"healthyVolunteers":17,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":69,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":59},"100624346","transdermal-testosterone-gel-for-female-sexual-interest-and-arousal-disorder-in-peri--and-post-menopause-100624346","NCT07408440","Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause","Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause - A Randomized, Double-blind, Placebo-controlled Trial for Improving Sexual Interest and Desire","TESTA MIND","Inclusion Criteria\n\n* Women 40-65 years; peri- or postmenopausal - with one of the following:\n\n  * Staging by STRAW+10: stage (-2) or above\n  * amenorrhea ≥12 mo\n  * Follicle stimulating hormone in menopausal range\n* FSIAD diagnosis according to the DSM-5: (3\u002F5 of the following symptoms)\n\n  * reduced or no interest in sex\n  * few or no thoughts about sex\n  * decreased sexual arousal or pleasure during sexual activity\n  * reduced or no arousal in response to visual, written, or verbal cues\n  * infrequent or no initiation of sexual activity within a relationship\n  * reduced or no sensations in the genitals\n\nThey must also have:\n\n* symptoms lasting 6 months or more\n* significant distress about their symptoms\n* symptoms that are not more accurately explained by a nonsexual mental health disorder, domestic abuse, medication, substance abuse, or another medical condition\n\n  * In a stable relationship or sexually active opportunity (as defined by participant)\n  * If on systemic estrogen ± progestin or local vaginal estrogen: stable dose ≥8 weeks before randomization and agrees to remain stable\n  * Able to consent and comply with study procedures\n\nExclusion Criteria\n\n* Current or recent (≤8 weeks) androgen therapy, dehydroepiandrosterone (DHEA), or anabolic steroids\n* Total T above premenopausal upper physiologic range at baseline (\\>55 ng\u002FdL)\n* History of hormone-dependent malignancy, untreated endometrial hyperplasia, or active gynecologic malignancy\n* Active severe psychiatric disorder (e.g., untreated major depression), substance use disorder, or relationship violence that precludes attribution of effect\n* Uncontrolled thyroid disease, significant liver disease, increased liver enzymes, or high cardiovascular risk judged unsafe by the primary care provider\n* Pregnancy, attempting conception, or breastfeeding\n* Dermatologic conditions preventing transdermal use; known hypersensitivity to the gel components","FEMALE","40 Years","65 Years",{"count":101,"type":23},150,[103],"NA","Hypoactive sexual desire disorder (HSDD) is described as the most common form of female sexual dysfunction, particularly affecting peri- and postmenopausal women and is associated with significant distress and reduced quality of life. The TESTA-MIND study will evaluate the efficacy and safety of a standardized compounded transdermal testosterone gel in a randomized, double-blind, placebo-controlled design to address the lack of FDA-approved options and limited high-quality evidence for treating decreased libido in women.",[106,107,108,27],"Menopause","Sexual Dysfunction","Libido Disorder","2026-02-12",{"date":111,"type":51},"2026-02-17",{"date":113,"type":23},"2026-04-01",{"date":115,"type":23},"2028-03-30",{"name":117,"class":58},"The University of Texas Health Science Center, Houston",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":97,"minAge":66,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":69,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":59},"100542515","phase-3-estradiol-and-testosterone-subdermal-implants-for-menopause-treatment-estime-100542515","NCT06343870","Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)","Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.","ESTIME","Inclusion Criteria:\n\n* menopause time of 2 to 6 years;\n* Body Mass Index between 25 and 30 kg\u002Fm2;\n* women hysterectomized and ovariectomized due to cervical cancer;\n* women with premature ovarian failure and under 40 years of age;\n* active sex life;\n* absence of severe depression and anxiety, confirmed by evaluation using the Beck (specific for depression) and Beck (specific for anxiety) questionnaires.\n\nExclusion Criteria:\n\n* disabling illnesses;\n* use of medications that inhibit sexual desire;\n* inability to answer the questionnaires;\n* altered routine exams and comorbidities:\n\n  * Severe hypertension with Blood Pressure measurement \\> 160 x 90 mmHg in two measurements\n  * clinical or subclinical thyroid dysfunction with Thyroid-stimulating hormone \\> 4 mIU\u002FL\n  * dyslipidemia - fasting triglyceride level \\> 400 mg\u002FdL\n  * presence of occult blood in feces\n  * hyperprolactinemia (\\>29ng\u002FmL)\n  * fasting blood glucose \\> 100 mg\u002FdL\n  * presence of osteopenia or osteoporosis\n  * BIRADS classification greater than or equal to 3 on mammography\n  * presence of endometrial echo \\> 4mm on transvaginal ultrasound\n  * presence of changes in oncotic colpocytology\n* diagnosis after psychological screening of moderate to severe anxiety\u002Fdepression.","60 Years",{"count":128,"type":23},140,[130],"PHASE3","Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.",[106,27,133],"Estrogen Deficiency",[135,136,137],"menopause","estrogen","testosterone","RECRUITING","2025-12-20",{"date":141,"type":51},"2025-12-29",{"date":143,"type":51},"2025-12-18",{"date":145,"type":23},"2027-04-30",{"name":147,"class":58},"University of Sao Paulo General Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":59},"100610450","testosterone-deficiency-and-endothelial-dysfunction-after-spinal-cord-injury-100610450","NCT07227740","Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury","Testosterone Deficiency and Endothelial Dysfunction in Spinal Cord Injury Related Cardiovascular Disease Mechanistic Insights and Therapeutic Prospects","Inclusion Criteria:\n\n* Between ages 18-89 years of age\n* Male Sex\n* History of motor complete (AIS A\u002FB) paraplegia (NLI T3 or Below)\n* Time since injury \\\u003C6 months at time of enrollment (Subacute injury)\n* Testosterone Deficiency defined as \\\u003C 300ng\u002FdL\n\nExclusion Criteria:\n\n* Overt cardiovascular disease assessed by a) medical history, b) physical examination c) electrocardiogram\n* Anaphylaxis to betadine, lidocaine, iodine\n* Active infection at time of enrollment.\n* Recent surgery (\\\u003C1 month) at time of enrollment.\n* History smoking tobacco (currently or in the past 12 months)\n* History of more than low-risk history of alcohol consumption\n* History of drug abuse\n* History of use of cardiovascular-acting (i.e. statins, beta-blockers) therapeutics\n* History of other health habits, medications, and supplements that could influence the outcome measures deemed by principal investigators and investigative team.","89 Years",{"count":157,"type":23},48,"Heart attacks and strokes are among the most common causes of premature death in individuals living with spinal cord injury (SCI) and appear to occur earlier in life. The factors that lead to the heighten and accelerated risk of heart attacks and strokes in adults living with SCI remain poorly understood. The investigators aim to uncover why this happens and find ways to prevent it. Our research focuses on how important cells which line blood vessels, called endothelial cells, function after SCI. The investigators test endothelial function in live conscious people with SCI. The investigators also study signaling molecules endothelial cells release called endothelial cell derived microvesicles (EMVs), which the investigators can measure in blood to tell us the health of endothelial cells. By using these rigorous tests of vascular function, the investigators have determined that endothelial cells appear dysfunctional after SCI. The investigators also know that many men with SCI have low testosterone levels. Our team has studied testosterone's effects on endothelial dysfunction and believe low testosterone may be contributing to endothelial dysfunction after SCI. By understanding these mechanisms, the investigators hope to improve the lives of those living with SCI and reduce their risk for heart attacks and strokes. The investigators propose to study the influence of testosterone on endothelial function by using state-of-the-art clinical and laboratory experiments to assess endothelial function in men with SCI with low and normal testosterone levels.",[160,161,27],"Spinal Cord Injuries","Endothelial Dysfunction",[163,164,165,166,167,168,169],"spinal cord injury","endothelial dysfunction","testosterone deficiency","extracellular vesicles","microvesicles","vasodilation","fibrinolysis","2025-11-20",{"date":172,"type":51},"2025-11-21",{"date":174,"type":51},"2025-07-15",{"date":176,"type":23},"2028-07-14",{"name":178,"class":58},"Craig Hospital",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":69,"phases":188,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":59},"100408650","phase-4-testosterone-treatment-for-erectile-dysfunction-and-multiple-sclerosis-100408650","NCT04601233","Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis","Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)","Inclusion Criteria:\n\n* Males, age 18 years and older, with a definite diagnosis of multiple sclerosis.\n* Low testosterone (\\\u003C300 ng\u002Fdl) on two successive blood draws before 9:00 am\n* Not in an intercurrent relapse.\n* Sexually active.\n* Have subjective complaints about erectile function and libido.\n* Must be willing and able to get labs drawn, complete questionnaires (BDI, MFIS, MSNQ, SDMT, MSQOL, ADAM, AUASS, SHIM, MSHQ, ICIQ, UDI, IIQ, MPQ) and commit to site visits schedule.\n\nExclusion Criteria:\n\n* Males unable to fulfill the above criteria and all female patients.\n* Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.\n* Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.\n* Patients who are taking anticoagulants or have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), urologic disease especially prostatic hypertrophy\u002Fnodules and testicular mass, or insulin-dependent diabetes.\n* Patients with an abnormal prostate as evidenced by known history of prostatic disease, symptoms suggestive of prostatic disease or elevated levels of prostatic specific antigen (PSA 4 ng\u002Fml or higher) measured within the last 12 months.\n* Patients with history or complaint of testicular mass.\n* Patients with hematocrit greater than 50%\n* Patients with major psychiatric illness\n* Patients with active alcoholism.\n* Patients with a history of drug abuse within the past five years.\n* Patients with BMI ≥ 35\n* Patients with generalized skin disease that may affect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.\n* Patients with history of pituitary disease.\n* Patients with a cholesterol level greater than 300 mg\u002Fdl.\n* Patients who are receiving or have received experimental therapies in the six months preceding enrollment.\n* Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).\n* Patients who have clinical evidence of Lyme disease.\n* Males who are trying to get their partner pregnant.\n* Patients on Finasteride\n* Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.\n* Any other contraindications according to the manufacturer's exclusion criteria.",{"count":187,"type":23},20,[189],"PHASE4","The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.",[192,193,27],"Multiple Sclerosis","Erectile Dysfunction",[192,193,27],"2025-08-28",{"date":197,"type":51},"2025-08-29",{"date":199,"type":23},"2026-06",{"date":201,"type":23},"2026-12",{"name":203,"class":58},"Tulane University",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":69,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100426470","phase-3-impact-of-peri-operative-testosterone-levels-on-oncological-and-functional-outcomes-in-radical-prostatectomy-100426470","NCT04833426","Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy","ENFORCE","Inclusion criteria\n\n1. Men aged 18 years or older\n2. Histologically confirmed prostate cancer\n3. Radical prostatectomy performed as primary treatment\n4. At least one-sided nerve-sparing procedure performed\n5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging\n6. Undetectable PSA level (\\\u003C0.1 µg\u002Fl or unmeasurable according to local protocol) within six weeks following RP\n7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain\n8. Testosterone deficiency, defined as total testosterone \\\u003C8 nmol\u002FL, or total testosterone between 8-12 nmol\u002FL with free testosterone \\\u003C225 pmol\u002FL, measured on two separate occasions, with normal or elevated luteinising hormone (LH)\n\nExclusion criteria\n\n1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)\n2. Previous use of testosterone therapy for any reason\n3. Pathological stage pT3b or pT4 in the RP specimen\n4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen\n5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed\n6. History of male breast cancer or liver tumour\n7. Uncontrolled hypertension\n8. General contraindications for TRT\n9. Allergy for components in TRT agent or placebo\n10. Use of vitamin K antagonists\n11. Body mass index (BMI) \\>30 kg\u002Fm²",{"count":128,"type":23},[130],"Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).",[215,216,27],"Prostatic Neoplasms","Hypogonadism",[218,219,216,32],"Prostate cancer","Prostatectomy","2025-05-01",{"date":222,"type":51},"2025-05-02",{"date":224,"type":51},"2022-12-12",{"date":226,"type":23},"2029-12",{"name":228,"class":58},"Canisius-Wilhelmina Hospital",10,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":18,"minAge":66,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":69,"phases":239,"briefSummary":240,"conditions":241,"keywords":258,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"100397880","phase-2-locomotor-training-with-testosterone-to-promote-bone-and-muscle-health-after-spinal-cord-injury-100397880","NCT04460872","Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury","Locomotor Training With Testosterone to Promote Bone and Muscle Health","Inclusion Criteria:\n\n* Men \\>18 years of age\n* Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \\>60-days\n* Low serum total testosterone (\\\u003C300 ng\u002FdL), bioavailable testosterone (\\\u003C110 ng\u002FdL), or free testosterone (\\\u003C46 pg\u002FmL or \\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\\\u003C6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone\n* Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m\u002Fs on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.\n* Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology\n* Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation\n* Willingness to administer TRT as instructed by the study staff and to abide by study protocol\n* Documented approval from the study physician verifying medical status\n\nExclusion Criteria:\n\n* Currently participating in another research protocol that may influence study outcomes.\n* Mental state that precludes understanding the study protocol.\n* Life expectancy \\\u003C12-months.\n* History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures\n* Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury\n* Current prostate, breast, or other organ cancer or a history of prostate or breast cancer\n* Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated\n* Serum prostate-specific antigen (PSA) \\>3.0 ng\u002FmL \\[men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng\u002FmL\\]\n* Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer\n* Currently seeking fertility or expected during the duration of the study\n* Gynecomastia\n* Hematocrit (HCT) \\>49%\n* Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)\n* Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (NYHA class III or IV)\n* Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events\n* History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia\n* LDL cholesterol \\>160 mg\u002FdL with history of any major CV event, defined above, within the last 12-months\n* Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and\u002For a major surgery scheduled at the time of screening\n* Liver enzymes (AST or ALT) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)\n* Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \\\u003C0.70 g\u002Fcm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)\n* Current anticoagulant therapy (contraindication for i.m. injections)\n* Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone\n* Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days\n* Acute use (\\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \\>7.5 mg\u002Fd prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration\n* Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)\n* Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration",{"count":238,"type":23},21,[71],"This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.",[242,160,243,244,245,246,247,248,216,249,250,251,252,253,254,255,256,27,28,257],"Spinal Cord Injury","Trauma, Nervous System","Wounds and Injury","Central Nervous System Diseases","Spinal Cord Diseases","Gonadal Disorders","Endocrine System Diseases","Genital Diseases, Male","Spinal Cord Trauma","Injuries, Spinal Cord","Walking, Difficulty","Gait Disorders, Neurologic","Locomotion Disorder, Neurologic","Wounds and Injuries","Nervous System Diseases","Hormone Deficiency",[75,259,260,261,262,263,264,265,266,267,268,269,74,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,242],"Testosterone enanthate","Testosterone undecanoate","Testosterone 17 beta-cypionate","Methyltestosterone","Androgens","Hormones","Hormone Substitutes, and Hormone Antagonists","Physiologic Effects of Drugs","Pharmacologic Actions","Therapeutic Uses","Anabolic Agents","Dual Energy X ray Absorptiometry","Lean Tissue Mass","Body Composition","Muscle Strength","Muscle Mass","Bone Mineral Density","Adipose Tissue","Body Fat","Density, Bone","Bone Formation","Bone Resorption","Bone Density Conservation Agents","Magnetic Resonance Imaging","Walking","Ambulation","Locomotor","Locomotion","Treadmill",{"date":289,"type":51},"2025-05-06",{"date":291,"type":51},"2021-01-31",{"date":293,"type":23},"2026-06-30",{"name":295,"class":58},"North Florida Foundation for Research and Education",2,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":305,"minAge":306,"maxAge":307,"enrollmentInfo":308,"targetDuration":310,"studyType":24,"phases":4,"briefSummary":311,"conditions":312,"keywords":318,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":330,"locationsCount":59},"100580747","fertility-enhancement-through-regenerative-treatment-in-ovaries-and-testes-100580747","NCT06841328","Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes","Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes: (FERTILE): Prospective Observational Study Evaluating Safety and Efficacy","FERTILE","Male patients:\n\n* Male patients aged 20 to 50 years.\n* Diagnosed with testicular failure (low testosterone) or hypogonadism (impaired gonadal function), or azoospermia (no sperm in ejaculate)\n* Suboptimal response to conventional treatments, such as testosterone replacement therapy (TRT) or fertility-enhancing medications (Clomiphene citrate or anastrozole).\n* General good health without significant contraindications to stem cell or stem cell-derived exosome therapy.\n* Willing and able to provide informed consent and comply with the study protocol.\n* Patients who have been evaluated for testicular failure and are seeking further treatment.\n\nFemale patients:\n\n* Female patients aged 20 to 50 years.\n* Diagnosed with premature ovarian failure (POF) or ovarian insufficiency, confirmed through clinical, hormonal, and imaging assessments.\n* Failure or suboptimal response to conventional treatments, such as hormone therapy.\n* General good health without significant contraindications to stem cell or stem cell-derived exosome therapy.\n* Willing and able to provide informed consent and comply with the study protocol.\n* Patients who have been evaluated for ovarian failure are seeking further treatment.\n\nExclusion criteria\n\n* Severe comorbid conditions, such as advanced cardiovascular disease, renal failure, or uncontrolled diabetes.\n* Active malignancies or history of cancer within the past 5 years.\n* Active infections or systemic inflammatory conditions.\n* History of testicular surgery or trauma that could interfere with the study outcomes.\n* Use of anticoagulants or medications that may contraindicate stem cell or stem cell-derived exosome therapy.\n* Participation in another investigational drug or treatment study within the past 6 months.\n* Contraindications to stem cell or stem cell-derived exosome therapy, such as immune deficiencies or allergies to any treatment components.\n* Severe neurological disorders or cognitive impairment may limit the ability to provide informed consent or follow study instructions.\n* Any condition that, in the investigator's opinion, could interfere with the study or pose an undue risk to the patient.\n* Women with a primary diagnosis of psychogenic ovarian dysfunction or infertility.\n* History of ovarian surgery or trauma that could interfere with the study outcomes.","ALL","20 Years","50 Years",{"count":309,"type":23},60,"12 Months","This study investigates the safety and efficacy of stem cell or stem cell-derived exosome therapy for gonadal failure, including testicular failure, hypogonadism, ovarian insufficiency, and premature ovarian failure (POF). Conducted at First IVF Clinic, Dubai, it will include 60 participants (30 males, 30 females) aged 20-50 years who have not responded to conventional treatments such as HRT, TRT, or ART.\n\nParticipants will receive intra-gonadal (testicular or ovarian) injections of stem cells or exosomes, with follow-ups at 3, 6, 9, and 12 months to monitor hormonal changes, gonadal function, and potential adverse effects. The study aims to determine whether regenerative therapy can restore hormone production, enhance reproductive function, and regenerate gonadal tissue, providing a novel, culturally appropriate fertility treatment in the UAE, where donor sperm and eggs are not permitted.\n\nBy bridging the gap between preclinical research and clinical application, this study could offer new hope to individuals with gonadal failure, advancing the field of regenerative reproductive medicine.",[313,314,315,27,316,317],"Gonadal Dysfunction","Gonadal Failure","Azoospermia","Stem Cells","Hypogonadism, Male",[319,320,321,322,323],"Premature Ovarian Failure","Testicular Failure","low testosterone","Stem cell therapy","Exosomes","2025-04-08",{"date":326,"type":51},"2025-04-10",{"date":324,"type":51},{"date":329,"type":23},"2028-04-30",{"name":331,"class":58},"Jumeirah American Clinic"]