[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypogonadism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypogonadism":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,77,104,131,162,188,217],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100171064","inherited-reproductive-disorders-100171064",false,"NCT01500447","Inherited Reproductive Disorders","The Molecular Basis of Inherited Reproductive Disorders","* INCLUSION CRITERIA:\n\nThe essential inclusion criteria include:\n\n1. failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low\u002Fnormal gonadotropins (due to substantial variability among patient presentations, this will be based on the clinical judgement of the Investigator), or\n2. abnormally early development of puberty, or\n3. normal puberty with subsequent development of low gonadotropin levels, or\n4. individuals with features indicating an increased risk of hypogonadotropic hypogonadism.\n5. Family members: both affected and unaffected family members are strongly encouraged to participate.\n\nEXCLUSION CRITERIA:\n\nSince hypogonadotropic hypogonadism is a rare condition, this protocol remains open to enrollment so that we may study all subjects that are both qualified and interested in participating.\n\nBecause HH represents a spectrum, where associated clinical findings may provide phenotypic clues to the assessment of inheritability and underlying physiology, exclusion criteria are very limited:\n\n* Patients who have additional pituitary deficiencies, effectively ruling out isolated GnRH deficiency, whether these deficiencies are congenital or acquired (e.g. secondary to malignancy, infection, or irradiation).\n* Patients who are taking medications known to affect GnRH secretion, such as corticosteroids or continuous opiate administration (or were taking them at the time of diagnosis).","ALL","6 Weeks","120 Years",{"count":20,"type":21},850,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- During puberty, children begin to develop into adults. Problems with the hormones released during puberty can affect the reproductive system. Some people have low hormone levels that severely delay or prevent puberty. Others start puberty abnormally early. Other people may have a normal puberty but develop reproductive disorders later in life. Researchers want to study people with reproductive disorders to learn more about how these disorders may be inherited.\n\nObjectives:\n\n\\- To learn how reproductive system disorders may be inherited.\n\nEligibility:\n\n* People with one of the following problems:\n* Abnormally early puberty\n* Abnormally late or no puberty\n* Normal puberty with hormonal problems that develop later in life\n* People who have not yet had puberty but have symptoms that indicate low hormone levels.\n\nDesign:\n\n* Participants will provide a blood sample for testing. They will complete a questionnaire about their symptoms. They will also have a scratch-and-sniff test to study any problems with their ability to smell.\n* Participant medical records will be reviewed. Participants will also provide a family medical history.\n* Family members of those in the study may be invited to participate.\n* Treatment will not be provided as part of this study.",[25,26,27,28],"Genetic Disorder","Infertility","Hypogonadism","Amenorrhea",[30,31,32,33,34,35],"Hypogonadotropic Hypogonadism","Kallmann Syndrome","Delayed Puberty","Hypothalamic Amenorrhea","Precocious Puberty","Natural History","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"2012-04-25",{"name":44,"class":45},"National Institute of Environmental Health Sciences (NIEHS)","NIH",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100634147","phase-2-clinical-trial-to-observe-the-effects-of-tamoxifen-on-testosterone-recovery-in-medically-castrated-prostate-cancer-patients-100634147","NCT07535905","Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients","Phase II Controlled Clinical Trial to Test Efficacy and Observe Longitudinal Effects of Tamoxifen for Testosterone Recovery in Medically Castrated Prostate Cancer Patients","REVIVE","Inclusion Criteria:\n\n* At least 18 years of age;\n* Ability to understand the purposes and risks of the trial and has signed a written informed consent form. Have a diagnosis of prostate cancer;\n* Patient received ADT for a duration of either 6 or 18-36 months as part of the curative intent treatment. Curative intent prostate cancer patients who completed ADT and have had no further ADT for the length of the last ADT injection depot formulation (e.g., if the last ADT injection depot formulation is for 3 months, the patient must have no ADT for 3 months after last injection)\n* Have effectively castrated testosterone (\\\u003C 1.7 nmol\u002FL \\[50 ng\u002FdL\\]) within 6 weeks of enrollment;\n* ECOG Performance status 0-2\n\nExclusion Criteria:\n\n* Harbouring certain CYP2D6 alleles (i.e. CYP2D6\\*4) or from the chronic use of a CYP2D6 inhibitor(s);\n* History of blood clots (venous thromboembolism or pulmonary embolism);\n* History of stroke or transient ischemic attack (TIA);\n* Reduced liver function within last 120 days prior to enrolment, defined as follows:\n\n  1. Total Bilirubin: 1.5 \\> upper limit of normal (ULN) (For Gilbert's syndrome, if total bilirubin is \\\u003C1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is greater than 1.5 x ULN, participant is ineligible;\n  2. AST(SGOT) and ALT(SGPT): \\> 2.5x ULN;\n  3. Or other liver disease as deemed ineligible by the investigator\n* Baseline QT\u002FQTc \\> 500ms;\n* Active therapy with selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g. paroxetine, a known CYP2D6 inhibitor);\n* Active therapy with coumarin-type anticoagulants;\n* Active therapy with cytotoxic agents;\n* Active therapy with aromatase inhibitors;\n* Other invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin;\n* Treatment with a non-approved or experimental drug during the 3 months before informed consent;\n* Patients known to have one of the following hereditary illnesses; galactose- intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;\n* Any other significant concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this trial;","MALE","18 Years",{"count":58,"type":21},96,"INTERVENTIONAL",[61],"PHASE2","Androgen deprivation therapy (ADT) is a cornerstone therapy in the treatment of curable prostate cancer (PCa). However, ADT often leads to a protracted testosterone recovery period in most men or absence of complete recovery in 10-25% of cases. The hypogonadal state has significant psychosocial and physical side effects. Therefore, limiting ADT effect's duration beyond the prescribed castration period is very compelling to patients and providers alike.\n\nTamoxifen, a well-established selective estrogen receptor modulator, offers a novel and cost-effective approach to accelerate testosterone recovery in men with secondary hypogonadism. This project addresses a critical gap in global cancer care by evaluating Tamoxifen as a viable solution for reducing the burden of delayed testosterone recovery and its associated side effects, particularly in resource-limited settings.",[27,64],"Prostate Cancer","NOT_YET_RECRUITING","2026-06-09",{"date":68,"type":40},"2026-06-10",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2030-10",{"name":74,"class":75},"University Health Network, Toronto","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":85,"targetDuration":87,"studyType":22,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"100634957","male-experiences-with-intra-cytoplasmic-sperm-injection-icsi-and-reduced-sperm-quality-100634957","NCT07546435","Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality","Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality - Have Anything Changed the Past 15 Years?","Inclusion Criteria:\n\n* ICSI treatment caused by reduced semen quality, language (danish)\n\nExclusion Criteria:\n\n* PESA\u002FTESA, Cancer, Sterilized males",true,{"count":86,"type":21},400,"4 Days","Several international studies indicate that men with reduced semen quality often feel overlooked in the context of fertility treatment. Men who undergo fertility treatment due to their own infertility, exhibit increased concern and experience more negative emotions such as loss, stigmatization, and low self-esteem - more so than men undergoing fertility treatment for other reasons.\n\nSince 2008, there has been limited research on the experiences of male patients with infertility in Denmark. Furthermore, there is generally very little knowledge regarding the testosterone levels (hypogonadism) of male infertile patients and its association with quality of life. Thus, there is a lack of updated insight into how infertile men experience their situation today. Additionally, the present study finds it relevant to examine whether men's needs and experiences in interactions with health professionals have changed over the past 15 years.",[90,27,91,92,93,94],"Psychological Experience in Fertility Treatment","Testosteron Levels","Quality of Life","Social Interaction","Infertile Males Comparied to Fertile Males","2026-04-16",{"date":97,"type":40},"2026-04-22",{"date":99,"type":40},"2026-02-13",{"date":101,"type":21},"2029-01-15",{"name":103,"class":75},"Peter Humaidan",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":76},"100537667","observation-of-environment-and-reproductive-endocrine-effects-100537667","NCT06280807","Observation of Environment and Reproductive-Endocrine Effects","OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, referring to sex assigned at birth (cis gender)\n2. Age \\> 8 years and weight \\>= 12 kg\n3. A diagnosis of hypogonadism, infertility or other reproductive dysfunction\n\n   Some specific diagnoses (as defined in standard guidelines) will include:\n   * Male or female hypogonadism\n\n     * Obesity\u002Fmetabolic syndrome related to hypogonadism.\n     * Other reproductive dysfunction (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)\n     * Premature Ovarian Insufficiency\n     * Isolated hypogonadotropic hypogonadism\n   * Polycystic Ovarian Syndrome\n   * Delayed Puberty\n   * Precocious puberty\n   * Perimenopause and post-menopausal states\n   * Androgen Excess States (Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.)\n\n   or\n\n   -Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)\n4. Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.\n2. Inability to follow up with the research study and\u002For perform study procedures, at the discretion of the PI or AI.\n3. Pregnant participants, less than 18 years of age, for their safety, since there is not a trained doctor on the study to give proper medical care to pregnant individuals less than 18 years of age.\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","8 Years","99 Years",{"count":114,"type":21},300,"Background:\n\nEndocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.\n\nObjective:\n\nTo learn how environmental factors may affect the endocrine and reproductive systems.\n\nEligibility:\n\nMales or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.\n\nDesign:\n\nAdult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.\n\nSpecific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:\n\nBody composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.\n\nResting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest.\n\n...",[27,117,34,118,28],"Hypergonadism","Late Puberty",[120,121,122],"Endocrine","Reproductive Disorders","Hypothalamic-Pituitary-Gonadal Endocrine Axis","2025-12-20",{"date":125,"type":40},"2025-12-23",{"date":127,"type":40},"2024-07-01",{"date":129,"type":21},"2039-03-31",{"name":44,"class":45},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":84,"sex":16,"minAge":56,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":59,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":76},"100551121","phase-4-adaptions-and-resiliency-to-multi-stressor-operations-100551121","NCT06455969","Adaptions and Resiliency to Multi-Stressor OpeRations","Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training","ARMOR","Inclusion Criteria:\n\n1. Age 18-40 years\n2. body mass index (BMI) 18-30 kg\u002Fm2\n3. weight stable (±10 lbs) in past 2 months\n4. takes part in moderate physical activity for at least 150 minutes\u002Fweek\n5. currently free of upper or lower body \u002Fextremity injury or impairment\n6. able to commit to study duration\n7. agrees to adhere to study requirements\n8. not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician\n9. in men, total testosterone concentration within normal physiological range (300-1000 ng\u002FdL)\n10. in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months\n\nExclusion Criteria:\n\n1. Current smoker\n2. current clinical diagnosis of an eating disorder\n3. use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes\n4. current oligo\u002Famenorrhea in women\n5. any metabolic or endocrine disease\n6. has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising\n7. currently pregnant or becomes pregnant during the study\n8. history of heart condition OR high blood pressure\n9. treating physician requires subject participates in medically supervised physical activity only\n10. history of drug addiction, or regular use of recreational drugs\n11. currently undergoing treatment for or have a history of mental health conditions\n12. irregular lab results (e.g., PSA \\>3 ng\u002FmL)\n13. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency\n14. Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates (oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit), calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU\u002Fday), anti-convulsants, depot medroxyprogesterone within 6 months.\n15. History of deep vein thrombosis, pulmonary embolism, or clotting disorders.\n16. History of stroke or myocardial infarction\n17. Serum 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n18. Thyroid dysfunction\n19. Serum creatinine \\> 2 mg\u002FdL\n20. Personal history or history of a first-degree relative with breast cancer\n21. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2x the upper limit of normal\n22. Serum bilirubin \\> 2 mg\u002FdL\n23. Serum alkaline phosphatase \\> 150 U\u002FL\n24. Plasma hemoglobin \\\u003C 10 gm\u002FdL\n25. Hematocrit \\> 50\n26. Fracture within the last 6 months.\n27. Serum testosterone level \\\u003C 270 or \\> 1070 ng\u002FdL\n28. Systolic blood pressure \\> 160 or diastolic blood pressure \\> 95\n29. Active substance abuse\n30. Triglycerides \\> 150 fasting\n31. History of hereditary angioedema\n32. History of chest pain at rest, during daily activities of living, or when performing physical activity\n33. Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years\n34. Recreational drug use more than 2 times per month in each of the previous 6 months\n35. Self-reported vision is worse than 20\u002F20.\n36. Personal history or history of a first-degree relative with breast cancer\n37. Experienced a fracture within the last 6 months\n38. participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration\n39. Diagnosed with eating disorder\n40. Have food allergies, intolerance, restriction, or special diet needs\n41. History of endometriosis\n42. Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement\n43. Have undiagnosed abnormal vaginal bleeding\n44. Currently breastfeeding or within 2 months after stopping breastfeeding\n45. Have dietary restrictions","40 Years",{"count":141,"type":21},120,[143],"PHASE4","Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.\n\nThe goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.",[146,27],"Musculoskeletal Injury",[148,149,150,151,152],"Military","Multi-stressor Training","Tendon","Muscle","Bone","2025-08-18",{"date":155,"type":40},"2025-08-24",{"date":157,"type":40},"2024-07-15",{"date":159,"type":21},"2026-08-01",{"name":161,"class":75},"Bradley Nindl",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":84,"sex":16,"minAge":56,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":76},"100535087","the-effect-of-sex-steroid-replacement-therapy-in-the-hypogonadism-and-transgender-active-duty-population-100535087","NCT06247267","The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population","The Effect on Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population on Bone Density, Fractures, Memory\u002FCognitive Function and Qualities of Life","Inclusion Criteria:\n\n* Male and female DoD health care beneficiaries\n* Ages 18-65\n* Diagnosed with primary hypogonadism or transgender treatment for at least 6 months\n* Under care for gender identity dysphoria\n* On stable dose of sex steroid hormonal therapy for at least 6 months prior to enrolling\n* Must be living in the Washington, D.C. area for at least 12 months following enrollment\n\nExclusion Criteria:\n\n* Pregnancy, plan for pregnancy in the next 12 months\n* Cardiac disease, especially coronary artery disease\n* Malabsorption disorder\n* Gastrointestinal surgeries\n* Significant renal or liver dysfunction\n* Seizure disorders\n* recent orders to move out of the geographic area\n* Age less than 18 years old or older than 65 years old\n* Scheduled for deployment","65 Years",{"count":171,"type":21},75,"It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female, respectively. In postmenopausal women, osteoporosis is a major concern secondary to the lack of estrogen. These patients also experience a number of physiological changes that affect their life permanently to include hot flashes, irritability, difficulty concentrating, depression and mental confusion. In hypogonadal men, testosterone deficiency could lead to higher prevalence of depression, osteoporosis, fracture and frailty. Given the new military policy starting to support treatment for gender identity dysphoria military personnel, the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months. These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics. However, as mentioned above, the lack of estrogen or testosterone in female and male, respectively, could cause several issue in their body composition, cognitive function and quality of life. We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory\u002Fcognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary\u002Fsecondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.",[27,174],"Gender Identity Dysphoria",[176,177,27],"Transgender","Gender dysphoria","2025-07-24",{"date":180,"type":40},"2025-07-29",{"date":182,"type":40},"2021-03-09",{"date":184,"type":21},"2025-08",{"name":186,"class":187},"Walter Reed National Military Medical Center","FED",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":59,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"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":196,"type":21},140,[198],"PHASE3","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).",[201,27,202],"Prostatic Neoplasms","Testosterone Deficiency",[204,205,27,206],"Prostate cancer","Prostatectomy","Testosterone deficiency","2025-05-01",{"date":209,"type":40},"2025-05-02",{"date":211,"type":40},"2022-12-12",{"date":213,"type":21},"2029-12",{"name":215,"class":75},"Canisius-Wilhelmina Hospital",10,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":59,"phases":226,"briefSummary":227,"conditions":228,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":46},"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":225,"type":21},21,[61],"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.",[229,230,231,232,233,234,235,236,27,237,238,239,240,241,242,243,244,202,245,246],"Spinal Cord Injury","Spinal Cord Injuries","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","Androgen Deficiency","Hormone Deficiency",[248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,229],"Testosterone","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","Testosterone Replacement Therapy","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":280,"type":40},"2025-05-06",{"date":282,"type":40},"2021-01-31",{"date":284,"type":21},"2026-06-30",{"name":286,"class":75},"North Florida Foundation for Research and Education"]