[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypogonadism-male\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypogonadism-male":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,72,99,125,149,177,205,231,267,294],{"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":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100366289","phase-2-testosterone-replacement-in-male-cancer-survivors-with-fatigue-and-low-testosterone-100366289",false,"NCT04049331","Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone","Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer","Inclusion Criteria:\n\n* Cancer survivors who have received chemotherapy and\u002For radiation therapy for their cancer and are now in remission for at least one year\n* Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias\n* Age: 18-54 years\n* Serum testosterone, measured by mass spectrometry (gold standard method), of \\\u003C348 ng\u002Fdl and\u002For free testosterone \\\u003C70 pg\u002Fml. The lower limits of the normal range for total testosterone in healthy young men (age 19-40 years), is 348 ng\u002FdL and the lower limits of free testosterone is \\\u003C70 pg\u002Fml in the Framingham Heart Study sample97. Therefore, young symptomatic men with total testosterone \\\u003C348 ng\u002Fdl could be considered testosterone deficient. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit. However; their free testosterone levels may still be below the lower limit of normal. Thus, we will also include men with free testosterone \\\u003C70 pg\u002FmL.\n* Self-reported fatigue. We have selected these symptoms because they are commonly reported in male cancer survivors. Fatigue will be defined as a score on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of \\\u003C40, which best divides cancer patients from the general population with 84% accuracy, and was used as the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)\n* Men with brain cancer (potential cognitive impairment)\n* Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months\n* Appetite stimulating agents e.g. megestrol acetate within the past 6 months\n* Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months\n* Baseline hematocrit \\>48%\n* PSA \\>4 ng\u002Fml in Caucasians; \\>3 ng\u002Fml in African-Americans\n* Men with 1st order relatives with a history of prostate cancer\n* Uncontrolled congestive heart failure\n* Severe untreated sleep apnea\n* Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months\n\n  o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score \\\u003C24\n* Serum creatinine \\>2.5 mg\u002FdL; ALT 3x upper limit of normal\n* Poorly controlled diabetes as defined by hemoglobin A1c \\>8.5%; Body mass index (BMI) \\>45 kg\u002Fm2\n* Untreated unipolar depression (treated depression with medications or counseling will be allowed\n* Bipolar disorder or schizophrenia","MALE","18 Years","54 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.",[27,28],"Hypogonadism, Male","Fatigue Syndrome, Chronic",[30,31,32],"testosterone","hypogonadism","cancer related fatigue","RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":37},"2021-03-22",{"date":41,"type":21},"2027-01-30",{"name":43,"class":44},"Seattle Institute for Biomedical and Clinical Research","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100458439","phase-2-testosterone-treatment-in-men-with-chronic-kidney-disease-100458439","NCT05249634","Testosterone Treatment in Men With Chronic Kidney Disease","Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease","Inclusion Criteria:\n\n* Men between ages of 18-85 years of age\n* eGFR 15-45 ml\u002Fmin\u002F1.73m2 by MDRD (Modification of Diet in Renal Disease) equation\n* Subnormal total serum T concentrations (\\\u003C300 ng\u002Fdl) on two separate occasions in morning\n* Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)\n* Normal iron stores as defined by serum ferritin ≥100 ng\u002FmL and transferrin saturation (TSAT) ≥20%.\n\nExclusion Criteria:\n\n* Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)\n* Hematocrit \\>48% (as per Endocrine Society guidelines)(15)\n* Treatment with erythropoiesis stimulating agents (ESA)\n* Uncontrolled blood pressure (\\>180\u002F100 mm Hg)\n* Heart Failure, class III or IV\n* Myocardial infarction, stroke, or heart surgery in the past 3 months\n* Breast cancer\n* History of prostate cancer\n* Prostate specific antigen (PSA) \\>4 ng\u002Fml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)\n* HIV or untreated hepatitis C\n* Untreated, severe obstructive sleep apnea\n* Initiated iron replacement in the last 3 months\n* deep venous thrombosis or pulmonary embolism in the last 3 months\n* recurrent (more than once) deep venous thrombosis or pulmonary embolism\n* use of warfarin\n* Planning to have children in the next one year","85 Years",{"count":55,"type":21},20,[24],"This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).",[27,59],"Kidney Disease, Chronic",[30,61],"CKD","2026-04-24",{"date":64,"type":37},"2026-04-30",{"date":66,"type":37},"2022-03-15",{"date":68,"type":21},"2028-12",{"name":70,"class":44},"St. Louis University",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":71},"100423791","phase-2-pain-alleviation-with-testosterone-in-opioid-induced-hypogonadism-100423791","NCT04798469","Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism","Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism","PATH","Inclusion Criteria:\n\n* Men, age 18 years and older.\n* Chronic non-cancer spinal pain.\n* Use of opioid analgesics for at least 6 months.\n* Serum total testosterone (measured by mass spectrometry) \\\u003C348 ng\u002FdL and\u002For free testosterone \\\u003C70 pg\u002FmL.\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* History of prostate cancer or breast cancer.\n* Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).\n* Use of testosterone within the past 6 months.\n* Baseline hematocrit \\>48%.\n* Prostate-specific antigen (PSA) level \\>4 ng\u002FmL in Caucasians or \\>3 ng\u002FmL in African-Americans.\n* Presence of prostate nodule or induration on digital rectal examination.\n* Uncontrolled congestive heart failure.\n* Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.\n* Serum creatinine \\>2.5 mg\u002FdL.\n* Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.\n* Diagnosis of bipolar disorder or schizophrenia.\n* Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.",{"count":81,"type":21},150,[24],"The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).",[85,86,27],"Opioid Use","Pain",[86,88,89],"Opioid Analgesics","Testosterone","2026-04-11",{"date":92,"type":37},"2026-04-14",{"date":94,"type":37},"2022-01-10",{"date":96,"type":21},"2027-12-30",{"name":98,"class":44},"Brigham and Women's Hospital",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100385673","phase-2-improving-cancer-related-fatigue-sexual-dysfunction-and-quality-of-life-in-older-men-with-cancer-and-androgen-deficiency-100385673","NCT04301765","Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency","TEMEC","Inclusion Criteria:\n\n* Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and\u002For radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \\\u003C60 months from their last treatment (chemotherapy and\u002For radiation therapy) will be included.\n* Age: 55 years and older\n* Life expectancy of at least 6 months.\n* Serum testosterone, measured by mass spectrometry (gold standard method), of \\\u003C348 ng\u002Fdl and\u002For free testosterone \\\u003C70 pg\u002Fml. The lower limits of the normal range for total testosterone in healthy men is 348 ng\u002FdL and the lower limits of free testosterone is \\\u003C70 pg\u002Fml in the Framingham Heart Study sample. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \\\u003C70 pg\u002FmL will be included.\n* Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \\\u003C40, which best divides cancer patients from the general population with accuracy.\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Men with current or prior history of prostate, breast, testicular, or adrenal cancers.\n* Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months\n* Hematocrit \\>48%, serum creatinine \\>2.5 mg\u002FdL\n* PSA \\>4 ng\u002Fml; nodule or induration on digital rectal exam\n* Severe untreated sleep apnea\n* Uncontrolled congestive heart failure\n* Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months\n* Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)\n* Previous stroke with residual cognitive or functional deficits\n* Inability to provide informed consent; MMSE score \\\u003C24\n* Poorly controlled diabetes as defined by hemoglobin A1c \\>10.0%\n* Body mass index (BMI) \\>40 kg\u002Fm2\n* Bipolar disorder or schizophrenia","55 Years",{"count":108,"type":21},230,[24],"This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.",[27,112,113],"Cancer","Fatigue",[30,32,115,31],"active cancer","2026-03-27",{"date":118,"type":37},"2026-03-31",{"date":120,"type":37},"2021-01-12",{"date":122,"type":21},"2026-11-01",{"name":43,"class":44},3,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":45},"100614343","phase-4-testosterone-replacement-therapy-in-hypogonadal-patients-with-prostate-cancer-under-active-surveillance-100614343","NCT07278362","Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance","Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance","Inclusion Criteria:\n\n* Males aged ≥ 18 years old\n* Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI, and had a second confirmatory biopsy within the last 12 months\n* Males diagnosed with low-risk prostate cancer undergoing active surveillance\n* Two confirmatory testosterone levels \\\u003C300 ng\u002FdL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests\n* Symptoms of low testosterone (Aging Male's Symptoms Score \\>27)\n* Able to obtain Testosterone medication through insurance or out-of-pocket\n* Willing and able to provide written informed consent and able to comply with study requirements\n\nExclusion Criteria:\n\n* Males \\\u003C18 years old\n* History of Testosterone Replacement Therapy (TRT) within the past year.\n* Current use of TRT\n* Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy\n* PSA \\>10 ng\u002FmL at baseline\n* Hematocrit \\> 51% at baseline\n* T3 or T4 disease\n* Uncontrolled cardiovascular disease and sleep apnea\n* History of breast cancer\n* Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation\n* Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket\n* Unable or unwilling to provide informed consent or comply with study requirements",{"count":133,"type":21},35,[135],"PHASE4","The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.",[138,27],"Prostate Cancer","NOT_YET_RECRUITING","2026-02-20",{"date":142,"type":37},"2026-02-23",{"date":144,"type":21},"2026-05-31",{"date":146,"type":21},"2032-05-31",{"name":148,"class":44},"University of Miami",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":55},"100569041","phase-3-52-week-study--24-month-long-term-extension-of-safety-pk--efficacy-of-xyosted-for-testosterone-replacement-in-male-adolescents-with-hypogonadism-100569041","NCT06689085","52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism","Open-Label, Multiple-Dose, 52-Week Study + 24-Month Long-Term Safety Extension to Evaluate the Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism","Inclusion Criteria:\n\n1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal deficiencies)\n2. Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening. Treatment naive participants are permitted to enroll.\n3. Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child to participate in the study\n4. Willing to provide assent for participation in the study\n5. Be a male 12 to \\\u003C 18 years of age at the time of consent\u002Fassent\n6. Have Legally Authorized Representative who is able to understand and comply with all study procedures and agrees to have the child participate in the study program as outlined in the protocol\n7. Requires chronic pharmacologic support for the initiation and\u002For continuation of pubertal maturation\n8. Have a body mass index (BMI)-for-age greater than the 5th percentile and weigh ≥ 30 kg.\n9. If sexually active with a female partner of child-bearing potential, agrees to:\n\n   1. Practice true abstinence including 30 days after the last IP administration, or,\n   2. Use 2 adequate forms of highly effective contraception, one of which should be a physical barrier, during the study and for 30 days after the last IP administration.\n\nExclusion Criteria:\n\n1. Has abnormal thyroid function tests at Screening. May supplement per usual clinical practice and rescreen up to two times.\n2. Has suspected or known constitutional growth delay in growth and puberty (CDGP)\n3. Has evidence of possible nutritional or gastrointestinal disorder that may impact growth (e.g., abrupt weight loss within the 3 months prior to Screening, unmanaged celiac disease, inflammatory bowel disease)\n4. Has a known allergy or hypersensitivity to XYOSTED, or to any of its ingredients (testosterone enanthate and sesame oil)\n5. Participants receiving prior treatment with testosterone who are not on a stable dose for at least 12 weeks prior to Screening.\n6. Has an allergy to foods or products containing sesame seeds or sesame oil\n7. Has Stage 1 hypertension, defined as the average of 2 or more seated right arm BP measurements exceeding the 95th percentile for age, sex, and height, or SBP ≥ 130 mm Hg and\u002For DBP ≥ 80 mm Hg at Screening or Day 1.\n8. Has a clinically significant abnormal clinical laboratory test value at Screening, as determined by the Investigator including hematocrit \\> 48%, or \\>50% for patients living at high altitude if not receiving testosterone treatment, or hematocrit \\> 52% if already receiving testosterone treatment.\n9. Has a history of deep venous thrombosis or pulmonary embolism\n10. Has evidence of a clinically significant 12-lead electrocardiogram (ECG) abnormality at Screening, as determined by the Investigator\n11. Has a current suspected or diagnosed (and unresected) tumor of the pituitary gland with the exception of Rathke's cleft cyst or a stable non-functioning pituitary microadenoma (ie, lesion size \\\u003C 10 mm that has not increased in size over a period of 1 year on repeat imaging), as determined by the Investigator\n12. Has an active malignancy or has received treatment for a malignancy within the 12 months before Screening\n13. Is currently receiving antipsychotic medication for any reason or is currently receiving selective serotonin reuptake inhibitor (SSRI) medication for depression\n14. Is receiving any other medication or has a condition that would preclude safe participation in the study or confound the evaluation of safety, as determined by the Investigator\n15. Has a history of suicidal behavior (i.e., actions intended to harm oneself), suicidal ideation (i.e., thoughts and plans about suicide), or suicide attempts\n16. Has any affirmative responses on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire to questions #3, #4, or #5 or any affirmative response to questions #1 or #2 within the past 12 months on the suicide ideation questions (first section) OR any affirmative response on the suicidal behavior questions (the second section).\n17. Is currently taking supraphysiologic doses of systemic glucocorticoids for more than 3 weeks, except for intermittent short courses of exogenous glucocorticoids as needed for the treatment of asthma\n18. Has received any other investigational compound within 1 month prior to screening or 5 half-lives of the investigational product (whichever is longer)\n19. Has received gonadotropin-releasing hormone (GnRH) agonists, aromatase inhibitors, androgens (eg, dehydroepiandrosterone \\[DHEA\\]), anabolic steroids such as oxandrolone, or other sex steroids within 12 months before the Screening visit, or would require these treatments at any time during the study.\n20. Receiving cytochrome P450 (CYP) 3A4 or P glycoprotein (P-gp) inhibitors\u002Finducers or medications that are metabolized by CYP3A4 or P-gp within 30 days of enrolment.\n21. Has a history of alcohol or drug abuse\n22. Has a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that would preclude participation in the study, as determined by the Investigator\n23. Has chronic urticaria or dermatographism\n24. Has 25-hydroxy-vitamin D blood level \\\u003C 20 ng\u002FmL. Participants with initial vitamin D blood measurement \\\u003C 20 ng\u002FmL may enroll while they receive supplementation per clinical practice","12 Years","17 Years",{"count":159,"type":21},100,[161],"PHASE3","This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.\n\nThe study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.",[27],[165,166],"primary hypogonadism","secondary hypogonadism","2026-02-16",{"date":169,"type":37},"2026-02-18",{"date":171,"type":37},"2025-03-07",{"date":173,"type":21},"2030-03",{"name":175,"class":176},"Halozyme Therapeutics","INDUSTRY",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":71},"100571464","endopat-device-for-endothelial-dysfunction-in-ed-100571464","NCT06720597","EndoPAT Device for Endothelial Dysfunction in ED","Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy","Inclusion Criteria:\n\n* Males 18 years old and above\n* Diagnosed with erectile dysfunction or hypogonadism\n\nExclusion Criteria:\n\n* Patients without the above criteria",{"count":185,"type":21},120,[187],"NA","To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound.\n\nTo evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy.\n\nTo investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy",[190,27,191],"Erectile Dysfunction","Endothelial Dysfunction",[193,190,194,191,195,89],"EndoPAT","Hypogonadism","ED","2026-01-29",{"date":198,"type":37},"2026-02-02",{"date":200,"type":37},"2025-08-13",{"date":202,"type":21},"2027-01",{"name":204,"class":44},"University of California, Irvine",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100618201","phase-4-ambulatory-blood-pressure-monitoring-abpm-study-in-hypogonadal-men-100618201","NCT07328542","Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal Men","A Multi-center, Open-label, Single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Study of Testosterone Cypionate Injection in Hypogonadal Men","Inclusion Criteria:\n\n* Male subjects aged ≥18 to ≤75 years of age (inclusive) at time of enrollment.\n* Body mass index (BMI) ≥17 kg\u002Fm\\^2 to \\\u003C 40 mg\\^2.\n* Willing and able to voluntarily provide written informed consent prior to initiation of screening or study-specific procedures.\n* Able to understand and to follow the protocol requirements, restrictions, and instruction, in the Investigator's opinion\n* Diagnosed with primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).\n* Hypogonadal males (individual serum testosterone concentrations \\\u003C350 ng\u002FdL and mean serum testosterone concentrations \\\u003C300 ng\u002FdL, determined from at least two samples separated at least 48 hours apart and obtained between 6 AM and 10 AM local time).\n* Testosterone therapy naïve or has discontinued current treatment and completed adequate washout of prior androgen therapy or any other therapy which causes significant change in serum androgen level i.e., clomiphene, anabolic steroids, compounded or over-the-counter androgenic steroid derivatives and dehydroepiandrosterone (45 days or 5 half-lives of the drug, whichever is longer, prior to collection of baseline serum testosterone samples). Washout must be completed prior to collection of baseline serum testosterone samples to determine study eligibility.\n* An office blood pressure measurement \\\u003C140 millimeters of mercury (mmHg) for SBP AND \\\u003C90 mmHg for DBP.\n* If the subject is on an antihypertensive regimen, he has been on stable dose for at least 4 weeks prior to study enrollment.\n* If the subject is on glucocorticoids \\>7.5 mg prednisone equivalent per day (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg), he has been on stable dose for at least 4 weeks prior to study enrollment with no intention of changing dose for the duration of the study.\n* Subjects with acceptable laboratory parameters\n\n  1. Hematocrit ≤ Upper limit of normal (ULN)\n  2. Hemoglobin ≤ 16 gm%\n  3. Prolactin ≤ ULN\n  4. PSA ≤ 4.0 ng\u002FmL (PSA level between 1.5 to 4.0 ng\u002FmL (both inclusive) for subject who is treated with 5-alpha reductase inhibitors (e.g., dutasteride, finasteride)\n  5. HbA1c ≤ 9 %\n  6. ALT ≤ 2.5 x ULN\n  7. AST ≤ 2.5 x ULN\n  8. Serum bilirubin ≤ 2.0 mg\u002FdL\n* No history of addiction to any recreational drug or drug dependence or alcohol abuse (including illicit steroid use) as per Investigator's judgement.\n* Subject is not considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.\n* Subject is not currently enrolled in another clinical study and will not enroll in another clinical study throughout the duration of the study.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity to study drug, including androgens, or product excipients.\n* Subjects with abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score \\> 19 points.\n* Subjects with history of, or current or suspected, prostate or breast cancer.\n* Subjects with history of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study enrollment except for diabetes, or renal disease\n* Subject with history of fluid or electrolyte imbalance.\n* Subject taking anticoagulant.\n* Subjects with history of uncontrolled heart failure, stroke or myocardial infarction within the past 6 months.\n* Subject with history of severe lower urinary tract symptoms in past 6 months.\n* Subjects with history of diagnosed, severe, untreated, obstructive sleep apnea.\n* Subjects working night shifts.\n* Subjects performing strenuous manual labor or exercise while wearing the ABPM monitor.\n* Subjects with chronic atrial fibrillation or any other chronic condition, which interferes with the ability to obtain precise ambulatory recordings.\n* Subject with polycythemia.\n* Subject with history of thrombophilia or venous thromboembolic events.\n* Subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).\n* Participation in any clinical study within 45 days or 5 half-lives of the drug before dosing of Investigational Product.\n* Loss of ≥ 350 ml (1 unit) of blood within 30 days of enrollment in the study.\n* Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study.","75 Years",{"count":214,"type":21},144,[135],"A Phase 4, multi-center, open-label, single-arm 24-hour Ambulatory Blood Pressure Monitoring (ABPM) study of Testosterone Cypionate Injection in Hypogonadal Men to assess change in 24-hour ambulatory blood pressure from Baseline to End of Treatment",[27],[219,220],"Hypogonadal Men","Ambulatory Blood Pressure Monitoring (ABPM)","2026-01-07",{"date":223,"type":37},"2026-01-09",{"date":225,"type":21},"2026-02",{"date":227,"type":21},"2027-08",{"name":229,"class":176},"Azurity Pharmaceuticals",6,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":239,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":244,"studyType":245,"phases":4,"briefSummary":246,"conditions":247,"keywords":253,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":71},"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":243,"type":21},60,"12 Months","OBSERVATIONAL","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.",[248,249,250,251,252,27],"Gonadal Dysfunction","Gonadal Failure","Azoospermia","Testosterone Deficiency","Stem Cells",[254,255,256,257,258],"Premature Ovarian Failure","Testicular Failure","low testosterone","Stem cell therapy","Exosomes","2025-04-08",{"date":261,"type":37},"2025-04-10",{"date":259,"type":37},{"date":264,"type":21},"2028-04-30",{"name":266,"class":44},"Jumeirah American Clinic",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":275,"targetDuration":4,"studyType":245,"phases":4,"briefSummary":277,"conditions":278,"keywords":281,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":71},"100556979","erectile-dysfunctions-gonadotoxicity-and-sexual-health-assessment-in-men-with-lung-cancer-100556979","NCT06532149","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)","EROS","Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic NSCLC\n* To be candidate to active treatment\n* Aged ≥ 18 anni (up to 75 years old)\n* To be sexually active in last 30 days before treatment start\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years\n* Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:\n* Cancer-related conditions that may preclude\u002Fundermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):\n\n  * History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)\n  * Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)\n  * Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics\n  * Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n  * Major psychological disorder and\u002For high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study",{"count":276,"type":21},80,"Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.\n\nThe aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC",[279,280,27,190],"NSCLC Stage IV","Sex Disorder",[282,283,284,190],"NSCLC","Sexual Health","Male hypogonadism","2024-08-08",{"date":287,"type":37},"2024-08-09",{"date":289,"type":21},"2024-08-05",{"date":291,"type":21},"2026-09-30",{"name":293,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":316,"locationsCount":71},"100351116","phase-4-effects-of-testosterone-undecanoate-vs-placebo-on-intrahepatic-fat-content-in-overweightobese-men-with-t2dm-or-prediabetes-and-hypogonadism-100351116","NCT03851627","Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight\u002FObese Men With T2DM or Prediabetes and Hypogonadism","52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese\u002FOverweight Men With T2DM\u002FPrediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Parameters","Test2Func","Inclusion Criteria:\n\n* prediabetes\u002FT2DM\n* male sex\n* HbA1c \\>=5.7% -9.0% or fasting glucose \\>=100mg\u002Fdl or postprandial glucose\\>= 140mg\u002Fdl\n* Age \\>=18 -75 years\n* BMI\\>=25kg\u002Fm²\n* Hypogonadism assessed by laboratory testing (testosterone \\\u003C 4,04ng\u002Fml (=14nmol\u002Fl) Metformin 8 weeks stable dose, SGLT2 inhibitors 3 months stable dose, DPP4 inhibitors 3 months stable dose, GLP1 RA 3 months stable dose and long acting insulin (basal insulin) 8 weeks stable dose\n* able and willing to not change diet and physical activity during enrollment in study\n* consent and able to give informed consent.\n\nExclusion Criteria:\n\n* Current testosterone treatment or testosterone replacement within the last 12 month\n* Serum creatinine\\>1,5mg\u002Fdl\n* Liver enzymes above 3 fold normal range\n* PSA\\>4.0μg\u002Fl\n* Hematocrit\\>50%\n* Known intolerance to testosterone undecanoate or any of its ingredients\n* Myocardial infarction within the last 12month\n* Stroke within the last 12 month\n* Untreated congestive heart disease\n* malignancy within the last 5 years before randomization\n* Prostate cancer or any suspicion thereof\n* Breast cancer\n* Liver tumor\u002Fcancer\n* Epilepsy\n* Migraine\n* Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.\n* patients on antidiabetic medication like Sulfonylurea or Glitazones.\n* Any other clinical condition that would jeopardize patients safety while participating in this clinical trial\n* Known autoimmune disease or chronic inflammatory condition\n* Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology\n* Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake\n* History of bariatric surgery\n* Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight\n* Subjects receiving antihypertensive medication and\u002For thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline\n* Uncontrolled\u002F untreated hypertension\n* Current treatment with systemic steroids at time of informed consent. (Treatment with local and inhaled steroids is allowed)\n* Donation of blood (\\> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study\n* Participation in another trial with an investigational drug within 30 days prior to informed consent.\n* Pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol.\n* contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT).\n* COPD Gold IV or recurrent acute or allergic asthma (for MPI)\n* Contraindications for cardiac stress test as acute myocardial infarction, instable angina, severe hypertension, myocarditis, life threatening rhythmic disorders without physical activity.",{"count":303,"type":21},32,[135],"The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these diseases. The prevailing hypothesis for NAFLD pathogenesis is the 'two-hit' model, with insulin resistance and hyperinsulinemia playing essential roles, which have a plethora of effects on hepatic lipid metabolism and can lead to accumulation of triglycerides in hepatocytes. Accepted treatment for NAFLD is lifestyle modifications. Sex hormones might be relevant in T2DM development and treatment. Low testosterone (T) has deteriorating effects on glucose levels, and aggravates in obesity as aromatization of T is enhanced. T deficiency is related to increases of visceral fat accumulation and associated with development of NAFLD. T replacement might be a successful way in hypogonadism to treat obesity and counteract progression of MEtSy,T2DM or CVD driven by visceral fat accumulation or NAFLD.\n\nPrimary Objective To investigate the effects on hepatic lipid content reduction of a therapy with Testosterone undecanoate 1000mg compared to placebo given for 52 weeks in patients with type 2 diabetes mellitus and hypogonadism.",[307,308,309,27],"Fatty Liver","Overweight\u002FObesity","Prediabetes\u002FType2 Diabetes Mellitus","2024-03-12",{"date":312,"type":37},"2024-03-13",{"date":314,"type":37},"2022-01-25",{"date":68,"type":21},{"name":317,"class":44},"Alexandra Kautzky-Willer"]