[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erectile-dysfunction-due-to-arterial-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erectile-dysfunction-due-to-arterial-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,89],{"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":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100628386","phase-2-trial-of-statin-therapy-effect-on-androgen-status-and-erectile-function-in-men-100628386",false,"NCT07460960","TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men","A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk","Inclusion Criteria:\n\n* male patients aged 40-65 years, sexually active\n* high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))\n* absence of previous statin therapy for 3 months\n* there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment\n* the invariance of concomitant therapy for 3 months, if the patient needs it.\n\nExclusion Criteria:\n\n* known statin intolerance\n* known hypogonadism\n* persistent forms of atrial fibrillation\n* active malignant neoplasm requiring treatment at the time of screening\n* known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.)\n* impaired renal function (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values)\n* chronic heart failure\n* a well-known diagnosis of mental illness\n* alcoholism and drug addiction\n* glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on)\n* participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent\n* the patient's inability to understand the essence of the study and consent to participate in it","MALE","40 Years","65 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category.\n\nMaterial and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg\u002Fday. Group Ros (n=75) will receive rosuvastatin 20 mg\u002Fday. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg\u002Fday and\u002For rosuvastatin to 40 mg\u002Fday will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months.\n\nResults. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.\n\nConclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.",[27,28,29,30,31,32],"Erectile Dysfunction Due to Arterial Disease","Atheroscleroses","Erectile Disfunction","Endothelial Dysfunction","Androgen Profile","Testosterone",[34,35,36,37,38,39,40,41,42],"cardiovascular diseases","erectile dysfunction","androgen status","atherosclerosis","statins","statin therapy","coronary artery disease","endothelial dysfunction","testosterone","RECRUITING","2026-03-12",{"date":46,"type":47},"2026-03-16","ACTUAL",{"date":49,"type":47},"2026-03-05",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Lomonosov Moscow State University Medical Research and Educational Center","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":76,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":55},"100505998","efficacy-of-low-intensity-shockwave-vs-radial-wave-for-treatment-of-erectile-dysfunction-and-pelvic-pain-100505998","NCT05868668","Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain","Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer","Shockwave","Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)\n\n1. Cis-gendered heterosexual adult males18 years old\n2. Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration.\n3. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months\n4. If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the study. Partially responsive ED is defined as inadequate response for desired sexual activity, or poorly maintained erection despite initially good response.\n5. Agreeable to attempt sexual intercourse at least 4 times per month for duration of study without being under the influence of alcohol or recreational drugs\n6. Morning total testosterone level over 300ng\u002FdL\n\nExclusion Criteria (ED):\n\n1. Nerve-injury related ED (\u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis)\n2. Untreated hypogonadism (morning total testosterone \\\u003C300 ng\u002FdL) or on androgen deprivation therapy in the last 12 months\n3. Predominately psychogenic ED based upon expert clinician opinion\n4. Peyronie's disease, palpable plaque or curvature\u002Fpenile anatomic abnormality that affects penetrative intercourse to any degree\n5. History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)\n6. History of penile injury or trauma (e.g, priapism, penile fracture)\n7. Use of intracavernosal injection for ED within the last year\n8. If diabetic, HbA1c 8% or higher within the past 12 months\n9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound\n10. Current tobacco smoker, or has smoked in the past year\n11. Poorly controlled hyperlipidemia\n12. Poorly controlled hypertension\n13. Severe cardiac disease or history of myocardial infarction\n14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression\n15. Patients currently using SSRI or psychotropic medication\n16. Severe ED based on IIEF-EF (score 10 or below)\n17. Current acute prostatitis\n\nChronic Pelvic Pain Syndrome Group:\n\nInclusion Criteria (CPPS): (all of the following)\n\n1. Adult males ≥18 years old\n2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine)\n3. Willing to do PFPT\n\nExclusion criteria (CPPS):\n\n1. Nerve-injury related pelvic pain (history of \u002Fspinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting pain in the pelvic region(Multiple sclerosis, Alzheimer's, Parkinsons disease)\n2. Acute prostatitis or any acute infection of the pelvic region\n3. History of pelvic trauma",{"count":65,"type":21},186,[67],"NA","The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.",[70,71,27,72,73,74,75],"Erectile Dysfunction Due to Arterial Insufficiency","Erectile Dysfunction","Chronic Pelvic Pain Syndrome","Chronic Prostatitis","Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Following Radiation Therapy",[77,78,79],"shockwave","radial wave","pelvic floor physical therapy","2026-01-20",{"date":82,"type":47},"2026-01-21",{"date":84,"type":47},"2023-09-19",{"date":86,"type":21},"2026-06",{"name":88,"class":54},"The Cleveland Clinic",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":55},"100617508","phase-2-clinical-trial-investigating-the-effect-of-exosomes-as-a-complementary-treatment-in-severe-to-moderate-erectile-dysfunction-100617508","NCT07319533","Clinical Trial Investigating the Effect of Exosomes as a Complementary Treatment in Severe to Moderate Erectile Dysfunction","Investigating the Effect of Exosome Derived From Human Fetal Umbilical Cord Mesanchymal Cells as Complimintary Treatment in Moderate to Severe Erectile Dysfunction","MSC","Inclusion Criteria:\n\nModerate or severe erectile dysfunction (according to IIEF-5) Non-satisfactory response to other treatments Generally Healthy males Not having severe past medical history\n\nExclusion Criteria:\n\nKnown allergy or history of hyperactivity to biological substances Peyronie's plaque Existing medical condition (severe or uncontrolled) Use of psychiatric medication Use of thyroid medication Hyopgonadism Hypergonadism Cancer History of prostatectomy Prostitis Autoimmune disease Recent trauma or surgery Ongoing systemic infection Skin lesion or infection at the site of injection","18 Years","70 Years",{"count":100,"type":21},70,[24],"The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction in overall healthy males, aged 18-70, with-out any severe active medical condition, with moderate to severe erectile dysfunction based on IIEF-5, and non-satisfactory response to other treatments (5PDEI). The main question it aims to answer is:\n\n• Is MSC-derived exosome safe and effective in treating patients with ED by improving IIEF-5 score?\n\nIf there is a comparison group: Researchers will compare the intervention group (Exosome receiving group) with control group (placebo receiving group) to see if exosomes are safe and effective in treating male adult patients with moderate-sever ED.\n\nParticipants will receive six weekly injections of normal saline or exosome (based on group), and will undergo necessarily follow up, and examinations and observation.",[71,104,27,70,105,106],"Erectile Dysfunction Associated With Type 2 Diabetes Mellitus","Erectile Dysfunction Due to General Medical Condition","Erectile Dysfunction Due to Neuropathy",[71,108,109,95],"Exosome","Mesanchymal Stem Cell","NOT_YET_RECRUITING","2025-12-21",{"date":113,"type":47},"2026-01-06",{"date":115,"type":21},"2026-01",{"date":117,"type":21},"2027-01",{"name":119,"class":54},"Labbafinejad Medical Center"]