[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"erectile-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:erectile-dysfunction":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,56,0,25,[9,42,73,104,130,155,178,201,224,249,273,301,323,348,379,401,424,446,467,494,515,536,559,586,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100643895","comparison-between-excision-and-primary-anastomosis-urethroplasty-and-tunica-vaginalis-graft-urethroplasty-100643895",false,"NCT07668973","Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.","Comparison of Outcome Between Excision and Primary Anastomosis Urethroplasty and Tunica Vaginalis Graft Urethroplasty in Patients With Bulbar Urethral Stricture Upto 2cm in Length : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with diagnosis of bulbar urethral stricture upto 2cm in length.\n* Patients aged between 18-50 years.\n* Patients with non-traumatic bulbar urethral stricture.\n* Isolated short (≤ 2 cm) bulbar urethral stricture\n* Patient is able and willing to comply with the postoperative protocol.\n\nExclusion Criteria:\n\n* Urethral stricture which is completely obliterated stricture.\n* Patients with history of hypospadias or previous open urethral surgery.\n* Patients with uncontrolled diabetes or Immunocompromised patients.\n* Patients unwilling for the follow-up.\n* History of pelvic radiation therapy\n* Patient with history of urethral instrumentation in last 3 months.\n* Lichen sclerosus related strictures.\n* Patients with history of erectile dysfunction, priapism or treatment to enhance erectile function.","MALE","18 Years","50 Years",{"count":21,"type":22},94,"ESTIMATED","INTERVENTIONAL",[25],"NA","Urethroplasty is considered as a gold standard in treatment of urethral stricture disease having success rate of more than 93% in terms of recurrence of stricture. The objective of the study is to compare the outcome between excision and primary anastomosis (EPA) urethroplasty, a transecting urethroplasty technique and Tunica Vaginalis Graft (TVG) Urethroplasty, a non-transecting urethroplasty technique, in patients with bulbar urethral stricture upto 2cm in length. It will be a Randomized Controlled Trial (RCT) in which 94 patients admitted in Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. The Group-A patients will undergo excision and primary anastomosis (EPA) urethroplasty while Group-B patients will undergo Tunica Vaginalis Graft (TVG) Urethroplasty. Non-probability convenience sampling will be carried out. Detailed history of urinary symptoms, Sexual function, catheterization, instrumentation, urinary tract infection and trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR) uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. Other parameters of study will be length of hospital stay, postoperative complication such as graft failure, wound infection, urinary tract infection and fistula formation. Data will be collected through proforma, which will be entered and analyzed using statistical package for social sciences version 26.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between qualitative variables. An Independent sample t-test will be applied for quantitative variables. P-value \\\u003C0.05 will be considered significant. It is anticipated that the Tunica Vaginalis Graft (TVG) Urethroplasty provides better outcome as compared to excision and primary anastomosis (EPA) urethroplasty.",[28,29],"Urethral Stricture","Erectile Dysfunction","NOT_YET_RECRUITING","2026-06-21",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":22},"2026-07",{"date":38,"type":22},"2027-07",{"name":40,"class":41},"Sahiwal medical college sahiwal","OTHER_GOV",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100642391","phase-4-l-citrulline-and-tadalafil-for-mild-to-moderate-erectile-dysfunction-100642391","NCT07642505","L-Citrulline and Tadalafil for Mild to Moderate Erectile Dysfunction","L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized Trial","Inclusion Criteria:\n\n* Male patients aged 30 to 70 years.\n* Erectile dysfunction for at least 3 months.\n* Mild to moderate erectile dysfunction, defined by International Index of Erectile Function-Erectile Function domain score from 11 to 25.\n* Stable sexual relationship during the study period.\n* Willingness to attempt sexual activity during the study period.\n* Ability to complete study questionnaires and attend follow-up visits.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Severe erectile dysfunction, defined by International Index of Erectile Function-Erectile Function domain score of 10 or less.\n* Current nitrate or nicorandil use.\n* Contraindication or hypersensitivity to tadalafil or L-citrulline.\n* Unstable cardiovascular disease, unstable angina, recent myocardial infarction or stroke, uncontrolled hypertension, or high-risk arrhythmia.\n* Severe hepatic impairment.\n* Severe renal impairment.\n* Untreated hypogonadism requiring hormonal treatment.\n* Hyperprolactinemia or uncontrolled endocrine disorder.\n* Major neurogenic erectile dysfunction, spinal cord injury, or previous radical pelvic surgery causing severe erectile dysfunction.\n* Significant Peyronie's disease preventing intercourse.\n* Active major psychiatric illness impairing reliable assessment.\n* Use of phosphodiesterase type 5 inhibitors, intracavernosal injection therapy, vacuum device therapy, testosterone therapy, L-arginine, L-citrulline, or erectile dysfunction nutraceuticals during the washout period before randomization.\n* Participation in another clinical trial during the previous 3 months.","30 Years","70 Years",{"count":52,"type":22},133,[54],"PHASE4","Erectile dysfunction is a common male sexual health problem that may affect quality of life and sexual relationships. Tadalafil 5 mg once daily is an established oral treatment for erectile dysfunction. L-citrulline is an oral nitric oxide pathway supplement that may improve erectile function by increasing L-arginine availability.\n\nThis randomized trial will compare three oral treatment regimens in men with mild to moderate erectile dysfunction: L-citrulline 1500 mg\u002Fday, tadalafil 5 mg\u002Fday, and the combination of L-citrulline 1500 mg\u002Fday plus tadalafil 5 mg\u002Fday. Participants will receive treatment for 12 weeks and will be followed at baseline, week 4, week 8, and week 12.\n\nThe primary outcome will be the change in the International Index of Erectile Function-Erectile Function domain score from baseline to 12 weeks. Secondary outcomes will include changes in IIEF-5\u002FSHIM score, Erection Hardness Score, SEP diary outcomes, treatment adherence, adverse events, and treatment discontinuation.",[29],[58,59,60],"L-citrulline","Tadalafil","International Index of Erectile Function","RECRUITING","2026-06-10",{"date":64,"type":34},"2026-06-12",{"date":66,"type":34},"2026-06-08",{"date":68,"type":22},"2026-12",{"name":70,"class":71},"Beni-Suef University","OTHER",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100627682","male-pelvic-floor-muscle-rehabilitation-exercises-100627682","NCT07451808","Male Pelvic Floor Muscle Rehabilitation Exercises","Male Pelvic Floor Muscle Rehabilitation (Kegel Exercises) Pelvic Floor Muscle Training","Inclusion Criteria:\n\n* Men 18 - 60 years of age\n* Must be able to achieve an erection\n\nExclusion Criteria:\n\n* Underlying medical conditions or poor health\n* Men who fall within the obese category based on standard body mass index (BMI) measurements",true,"60 Years",{"count":83,"type":22},100,[25],"Phase I\n\nG128 Study Objective\n\nThe ischiocavernosus (IC) and bulbospongiosus (BS) muscles are vital components of the superficial perineal layer, serving as the foundation for male sexual health and performance. These muscles play a primary role in achieving and maintaining erections by compressing the veins to trap blood within the erectile tissues. Furthermore, they are responsible for the rhythmic contractions necessary for ejaculation and the physiological sensations associated with orgasm.\n\nBeyond their role in sexual function, these muscles provide critical structural support to the pelvic floor and assist in urinary control. By working in tandem, the IC and BS muscles ensure penile rigidity while stabilizing the surrounding pelvic structures. Maintaining the strength and coordination of these muscles is essential for overall reproductive health and the prevention of pelvic floor dysfunction.\n\nThe primary objective of this clinical trial is to evaluate the clinical efficacy and therapeutic potential of Exercise G128 in strengthening the male pelvic floor musculature. Furthermore, the study aims to establish a comprehensive safety profile for Exercise G128 during active participation. The research seeks to address the following core investigative questions:\n\nTo what extent does Exercise G128 improve the tonicity and contractile strength of the IC and BS muscles?\n\nWhat is the incidence and nature of adverse medical events or physiological stressors reported by participants while performing the Exercise G128 protocol?\n\nResearchers will conduct a comparative analysis, benchmarking the physiological outcomes of Exercise G128 against existing clinical data regarding the efficacy of traditional Kegel exercises.\n\nParticipant Requirements:\n\nAdhere to a structured regimen, performing Exercise G128 four times weekly over a one-month intervention period.\n\nAttend bi-weekly telehealth consultations via video conferencing for supervised clinical assessments, progress monitoring, and physiological testing.\n\nMaintain a detailed daily log documenting functional progress, as well as any instances of physical exertion or soreness that necessitated a temporary cessation of the exercise protocol.",[29,87,88],"Urinary Incontinence","Premature Ejaculation",[90,91,92,93,94,95,96],"Dripping or leakage","urinary incontinence","Kegel exercises for men","ischiocavernosus muscle","bulbospongiosus muscle","Erectile dysfunction (ED)","Premature ejaculation","2026-06-07",{"date":62,"type":34},{"date":68,"type":22},{"date":101,"type":22},"2027-12",{"name":103,"class":71},"Dream Video LLC",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":72},"100638357","a-single-arm-study-of-extracorporeal-shockwave-therapy-for-management-of-erectile-dysfunction-100638357","NCT07592533","A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction","A Single Arm Study of EXtracorporeal Shockwave Therapy for mAnagement of ereCtile dYsfunction (EXSTACY Study)","EXSTACY","Inclusion Criteria:\n\n1. Patient is over the age of 18\n2. Patient has a natal penis (not a neophallus)\n3. Patient has ED (defined as IIEF-EF of 25 or less) and EHS \\\u003C 2 on at least 50% of sexual encounters\n4. Patient understands and is able to articulate necessary study procedures and tests\n5. Patient has the mental capacity to provide written and verbal informed consent\n6. Patient endorses the ability to comply with study procedures throughout the duration of the study\n\nExclusion Criteria:\n\n1. Placement of a penile prosthesis (malleable or inflatable type)\n2. Have a serious medical condition\u002Fillness that makes safety or compliance with study procedures and\u002For engagement in sexual activity inadvisable in the opinion of the PI\n3. Untreated severe psychological disease (e.g., psychosis, bipolar disorder)",{"count":113,"type":22},157,[25],"This is a device study (while the device has been patented and cleared by the FDA, the indication of the use for Erectile Dysfunction has been yet approve). EXSTACY is a study to collect information on which patients who have trouble getting or keeping an erection rigid enough for sex (sometimes known as Erectile Dysfunction or ED) benefit from light intensity shockwave therapy (LI-SWT). LI-SWT is a form of energy transfer to the penis that has been shown to help some men with ED in studies over the past decade. This study will collect information about patients prior to treatment to determine what predicts a good outcome. The investigators hope that this information will help decide which patients are likely to benefit from LI-SWT and which patients should consider other treatments for ED.",[29],[118,119,120],"Erectile dysfunction","Shockwave therapy","Single-arm study","2026-05-11",{"date":123,"type":34},"2026-05-18",{"date":125,"type":34},"2024-09-10",{"date":127,"type":22},"2027-12-31",{"name":129,"class":71},"University of California, San Francisco",{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100634297","phase-2-efficacy-of-intracavernosal-xeomin-with-tadalafil-for-mild-moderate-erectile-dysfunction-100634297","NCT07537855","Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction","Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study","Inclusion Criteria:\n\n* Written informed consent obtained from the subject\n* History of ED for at least 6 months prior to screening, defined as \"the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse\" (NIH), the diagnosis of ED has to be confirmed by a physician\n* Understanding of study procedures and willingness to abide by all procedures during the course of the study\n* Male subject aged ≥18 to ≤ 80 years at visit 1\n* Have a monogamous relationship with a female sexual partner (vaginal penetration required for several of the primary efficacy variables) for at least 6 months prior to screening\n* Highly motivated to obtain treatment for ED\n* History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose)\n* BW \\\u003C50 kg\n* Diagnosis of spinal cord injury\n* ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease (e.g., hypopituitarism, hypothyroidism, or hypogonadism)\n* History of penile implant.\n* The presence of clinically significant penile deformity in the opinion of the investigator.\n* Concomitant diagnosis of Peyronie's disease\n* Patients with chronic stable angina treated with long-acting nitrates, or patients with chronic stable angina who have required short-acting nitrates in the last 90 days, or angina occurring during sexual intercourse in the last 6 months.\n* Patients having met the criteria for unstable angina within 6 months prior to Visit 1, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to Visit 1, or percutaneous coronary intervention (e.g., angioplasty or stent placement) within 90 days prior to Visit 1.\n* Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate \\>100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate \\>100 bpm for 30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter-defibrillator.\n* A history of sudden cardiac death (arrest) despite medical or device therapy.\n* Any evidence of congestive heart failure within 6 months prior to Visit 1.\n* A significant conduction defect within 90 days prior to Visit 1.\n* Systolic blood pressure \\>170 or \\\u003C90 mm Hg or diastolic blood pressure \\>100 or \\\u003C50 mm Hg at screening (if stress is suspected, retest under basal conditions), or patients with malignant hypertension.\n* \\\u003C12 weeks since most recent injection of BTX-A\u002FB into any body region for any indication\n* Neurological disorder associated with neuro muscular dysfunction of any kind in medical history.\n* Planned concomitant treatment with BTX -A\u002FB of any body region during the study.\n* Known hypersensitivity to human serum albumin, sucrose, or the active substance BTX-A.\n* Generalized disorders of muscles activity (e.g. myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study.\n* Any condition that would interfere with the patient's ability to provide informed consent or comply with study instructions, would place patient at increased risk, or might confound the interpretation of the study results.\n* Current treatment with nitrates (as outlined in previous Exclusion Criterion, cancer chemotherapy, or anti-androgens.\n* History of drug, alcohol, or substance abuse within the past 6 months.\n* Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.\n* Treatment within the last 30 days with a drug or device that has not received regulatory approval at the time of study entry.\n* Ongoing severe or uncontrolled systemic disease, current malignancy, hemophilia, or HIV infection in medical history.\n* Severe or uncontrolled respiratory disease in medical history.\n* Evidence or suspicion that the subject is not willing or unable (e.g. Due to severe cognitive communication impairment) to understand the information that is given to him as part of the informed consent, in particular regarding the risks and discomfort which he would agree to be exposed to.\n* Any reason which in the investigator's opinion is likely to compromise the subject's ability to participate in the study.\n* Subject who is imprisoned or is lawfully kept in an institution\n* Participation in a clinical study within 12 weeks prior to screening or planned participation during this study.\n* Previous participation in this clinical study.","80 Years",{"count":139,"type":22},30,[141],"PHASE2","Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.",[29],[145,146],"xeomin","Incobotulinumtoxin A","2026-05-07",{"date":121,"type":34},{"date":150,"type":22},"2026-06",{"date":152,"type":22},"2028-06",{"name":154,"class":71},"Northwestern University",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":72},"100263274","helping-men-adhere-to-sexual-rehabilitation-following-prostate-cancer-surgery-100263274","NCT02706561","Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery","Inclusion Criteria:\n\n* As per medical record, early stage prostate cancer (Pathologic Stage 1\u002F2 with Gleason score \\\u003C\u002F=8; or Pathologic Stage 3 with Gleason score =\u002F\\\u003C 7)\n* As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution\n* As per medical record, ≤ 9 months post-RP\n* As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)\n* As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC\n* In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English\n\nExclusion Criteria:\n\n* Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.\n* Currently on or has a history of being an Androgen Deprivation Therapy (ADT)\n* Has any indication of Prostate-Specific Antigen (PSA)\n* As per self report, specific injection phobia\n* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.\n* As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.","21 Years",{"count":163,"type":22},224,[25],"The purpose of this study is to test two different ways to help men with sexual rehabilitation.",[167,29],"Prostate Cancer",[169],"15-317","2026-04-07",{"date":172,"type":34},"2026-04-08",{"date":174,"type":4},"2015-12-08",{"date":68,"type":22},{"name":177,"class":71},"Memorial Sloan Kettering Cancer Center",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":50,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":72},"100596657","phase-1-stem-cells-for-erectile-dysfunction-post-ralp-100596657","NCT07048314","Stem Cells for Erectile Dysfunction Post RALP","A Randomized Clinical Trial to Assess Safety and Efficacy of Allogeneic Adipose-derived Mesenchymal Stem Cells in Promoting the Recovery of Erectile Function Post Radical Retropubic Prostatectomy of Localized Prostate Cancer","Inclusion Criteria:\n\n1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.\n2. Men aged between 40 and 70 (inclusive) years old\n3. Localized prostate cancer: Clinical stage T1-T2, N0, M0\n4. Gleason score \\\u003C 7\n5. Pre-op IIEF-5 \\>20 (Appendix A)\n6. Testosterone serum: \\> 300ng\u002Fdl with normal Free Testosterone\n7. Life expectancy of at least 10 years\n8. Performance status of ≤ 2 (Zubrod scale). (Appendix B)\n9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution\n10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery\n11. Supportive partner willing to complete sexual survey questionnaire (Appendix D)\n12. PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery.\n13. Patient need cardiac clearance by the cardiologist\n\nExclusion Criteria:\n\n1. Penile anatomical abnormalities (Peyronie's disease)\n2. Hypogonadism\n3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)\n4. Patients with AST levels above 40U\u002FL ; ALT levels above 33 U\u002FL and Glucose levels above 180 mg\u002Fdl and psychiatric disorders that require medication\n5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.\n6. Any previous penile implant or penile vascular surgery\n7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .\n\n   \\-","40 Years",{"count":187,"type":22},40,[189,141],"PHASE1","This is a phase 1\u002F2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.",[29,167],"2026-03-16",{"date":194,"type":34},"2026-03-19",{"date":196,"type":22},"2026-03-10",{"date":198,"type":22},"2027-06-30",{"name":200,"class":71},"The Methodist Hospital Research Institute",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":80,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":72},"100626958","the-effectiveness-of-exercise-in-the-treatment-of-erectile-dysfunction-and-premature-ejaculation-100626958","NCT07442396","The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation","The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation: a Randomized Controlled Trial.","Inclusion Criteria\n\n* Male individuals aged 25-45 years\n* Individuals diagnosed with erectile dysfunction and premature ejaculation\n* Individuals who voluntarily agree to participate in the study and sign the informed consent form\n* Individuals who have the physical and cognitive capacity to participate in pelvic floor physiotherapy applications\n\nExclusion Criteria\n\n* Individuals with a history of surgery in the pelvic region\n* Individuals with a diagnosis of neurological disease or neurological disorder that may affect pelvic floor muscle function\n* Presence of active infection, inflammation, or painful pathology in the pelvic region\n* Individuals who regularly use medications that significantly affect sexual function\n* Individuals with serious psychiatric illness or cognitive impairment that may hinder study compliance","25 Years","45 Years",{"count":211,"type":22},50,[25],"The aim is to investigate the effectiveness of exercise in the treatment of erectile dysfunction and premature ejaculation.",[29,88],"2026-03-02",{"date":217,"type":34},"2026-03-03",{"date":219,"type":34},"2026-03-01",{"date":221,"type":22},"2026-07-10",{"name":223,"class":71},"Uskudar University",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":232,"maxAge":137,"enrollmentInfo":233,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":248},"100626082","safety-follow-up-study-of-cellgram-ed-in-post-radical-prostatectomy-erectile-dysfunction-100626082","NCT07431008","Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction","A Safety Follow-up Study of a Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Cellgram-ED (Autologous Bone Marrow-Derived Mesenchymal Stem Cells) in Patients With Post-Radical Prostatectomy Erectile Dysfunction","Cellgram-ED","Inclusion Criteria:\n\n* Participants who previously participated in the parent clinical trial and received the cell therapy (Cellgram-ED).\n* Participants who have provided written informed consent to participate in this safety follow-up study.\n\nExclusion Criteria:","19 Years",{"count":234,"type":22},32,"OBSERVATIONAL","This phase II clinical trial with safety follow-up is designed to evaluate the efficacy and safety of Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) administered via intracavernous injection in patients with erectile dysfunction after radical prostatectomy.",[29],"2026-02-20",{"date":240,"type":34},"2026-02-24",{"date":242,"type":34},"2024-12-26",{"date":244,"type":22},"2030-01-10",{"name":246,"class":247},"Pharmicell Co., Ltd.","INDUSTRY",4,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":80,"sex":17,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100528973","safety-and-efficacy-of-the-vertica-rf-device-for-the-treatment-of-ed-100528973","NCT06167733","Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED","Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction","Inclusion Criteria:\n\n* Adult, heterosexual, males between 22 and 85 years of age\n* Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).\n* Subjects with an IIEF-EF score between 11-21\n* Steady relationship for at least 3 months\n* Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month\n* Subject is willing to sign informed consent and follow study protocol procedures\n* Subject has a smartphone\n\nExclusion Criteria:\n\n* Castrate and late onset hypogonadism\n* History of Priapism or Peyronie's Disease\n* Surgery or radiotherapy of the pelvic region\n* Anatomic penile deformations or penile prosthesis\n* Treatment with antiandrogens\n* Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)\n* History of urothelial or colorectal cancer\n* Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy\n* Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days\n* Subjects who are taking anticoagulation or anti-platelet therapy\n* History of psychiatric disorders, premature ejaculation and drug or alcohol abuse\n* Subjects who are incarcerated\n* Subjects who are cognitively challenged\n* Serious heart or lung disease\n* Pregnant partner","22 Years","85 Years",{"count":259,"type":22},98,[25],"Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.",[29],"2026-02-11",{"date":265,"type":34},"2026-02-13",{"date":267,"type":34},"2023-11-29",{"date":269,"type":22},"2026-10-01",{"name":271,"class":247},"OHH-MED Medical Ltd",7,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":287,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":72},"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":281,"type":22},120,[25],"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",[29,285,286],"Hypogonadism, Male","Endothelial Dysfunction",[288,29,289,286,290,291],"EndoPAT","Hypogonadism","ED","Testosterone","2026-01-29",{"date":294,"type":34},"2026-02-02",{"date":296,"type":34},"2025-08-13",{"date":298,"type":22},"2027-01",{"name":300,"class":71},"University of California, Irvine",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":72},"100548762","effectiveness-of-pelvic-floor-therapy-for-the-management-of-erectile-dysfunction-and-premature-ejaculation-100548762","NCT06425211","Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.","Inclusion Criteria:\n\nOverall:\n\n* Men over 18 years of age\n* Erectile dysfunction or premature ejaculation for at least 6 months\n* Sexual activity with a heterosexual partner at least once a week\n* Signing of informed consent before the start of the study\n\nFor the premature ejaculation group:\n\n* Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria\n* Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11\n\nFor the erectile dysfunction group:\n\n* Clinical diagnosis of primary erectile dysfunction\n* International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26\n\nExclusion Criteria:\n\n* Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months\n* Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction\n* History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction\n* History of pelvic radiotherapy\n* Pacemaker or cardiac arrhythmia, epilepsy\n* History of spinal cord trauma or spinal surgeries.\n* Inability to attend therapies or controls\n* Illiteracy or cognitive disability that prevents you from completing the questionnaires\n* Psychiatric, psychological disorders, or cognitive deficiencies\n* Injuries in the area of application of the therapy\n* Active pelvic organ cancer","100 Years",{"count":309,"type":22},66,[25],"The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:\n\nWhat is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?\n\nPatients will:\n\n* Have an initial consultation of pelvic floor rehabilitation before therapy.\n* Be given pelvic floor therapy.\n* Have a secondary consultation of pelvic floor rehabilitation after therapy.\n\nThree intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.",[29,313,88,314],"Premature (Early) Ejaculation","Pelvic Floor; Weak","2026-01-22",{"date":317,"type":34},"2026-01-23",{"date":319,"type":34},"2021-10-30",{"date":68,"type":22},{"name":322,"class":247},"Boston Medical Group",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":80,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":72},"100537112","the-impact-of-a-plant-based-meat-meal-versus-an-animal-meat-meal-on-erectile-function-in-healthy-men-100537112","NCT06273592","The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.","The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men","ERECTION 2","Inclusion Criteria:\n\n* Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted. (If the subject is a fluent Spanish and\u002For other language speaker, subject must also be fluent in English (understanding and speaking) to be eligible for this study.)\n* IIEF score greater or equal to 22\n* Subject is currently taking no medication other than prn MDIs No change in supplements if applicable\n* Subject will have had penile sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment\n* Male (biological) aged 18-32 years old\n* Lives within commuting distance of Montefiore Health System\n* Subject's significant other (if applicable) agrees to support the subject during the study\n* Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording\n* Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording\n* Subject agrees to not view, read, or otherwise consume erotic or pornographic material for at least 24 hours prior to the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording\n* Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording\n* Subject agrees to come to Montefiore to undergo Rigiscan™ training\n* Subject agrees to only consume\u002Fdrink permitted food\u002Fbeverages\n* Subject agrees to attend all in person visits at Montefiore and to undergo all blood draws and other testing\n* Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth and to not use toothpaste for 24 hours preceding Rigiscan testing. Tooth brushing is otherwise permissible.\n* BMI \\\u003C28.5, BMI \\>=18.5, weight \\>110 lbs\n* Subject agrees to comply with the study procedures and visits\n* Subject exercises for at least 15 minutes at least two times per week\n* If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.\n* If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings when food is provided.\n* If enrolled, subjects agree to fast when requested to fast\n\nExclusion Criteria:\n\n* Relevant dietary allergy\n* Vegetarian or Vegan dietary pattern\n* History of an eating disorder and\u002For food addiction\n* Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure \\> 150mmHg and\u002For diastolic blood pressure \\>100mmHg on Visit one. Heart rate \\>99 on Visit one. Systolic blood pressure \\\u003C 85mmHg and\u002For diastolic blood pressure \\\u003C 50mmHg on Visit one. Heart rate \\\u003C 35 on Visit one\n* BMI \\>=28.5, BMI \\\u003C18.5, or weight \\\u003C= 110lbs\n* Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma\n* Subjects who are taking benzodiazepines, stimulants (e.g. for ADHD), SSRI, anti-depressants and\u002For beta blockers\n* Obstructive sleep apnea (OSA) diagnosis or an ongoing evaluation for possible OSA\n* Score greater than 2 on the STOP-Bang OSA screening tool\n* Having the diagnosis of Restless Leg Syndrome\n* Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night). The above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014\n* History of kidney disease or hyperkalemia\n* Subject has received an investigational drug within 30 days prior to signing consent\n* Erectile dysfunction\n* Has any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures\n* Currently undergoing treatment for Peyronie's Disease\n* Abnormal Testosterone or Thyroid Stimulating Hormone level\n* Treated hypogonadism or hypothyroidism\n* Planned travel during the study\n* History of substance abuse in the last 12 months\n* Illicit drug use, smoking, or vaping within 4 weeks\n* Upper respiratory illness within two weeks on screening\n* If profession requires being on call, no overnight or on call duties during the study\n* Subject reports any communicable skin or venereal disease\n* Transgender status (Individuals who have undergone or are undergoing hormone replacement therapy or who have undergone gender affirming surgery. Individuals who plan to begin hormone replacement therapy or to undergo gender affirming surgery during the study.)\n* HIV positive status via direct medical history\n* Subject reports rash or lesion on the penis or surrounding area","32 Years",{"count":139,"type":22},[25],"The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.",[29],[337,338,339,340],"Diet","Erectile function","Plant-based","Animal-based",{"date":317,"type":34},{"date":343,"type":34},"2024-09-19",{"date":345,"type":22},"2027-06",{"name":347,"class":71},"Montefiore Medical Center",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":367,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":72},"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":357,"type":22},186,[25],"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.",[361,29,362,363,364,365,366],"Erectile Dysfunction Due to Arterial Insufficiency","Erectile Dysfunction Due to Arterial Disease","Chronic Pelvic Pain Syndrome","Chronic Prostatitis","Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Following Radiation Therapy",[368,369,370],"shockwave","radial wave","pelvic floor physical therapy","2026-01-20",{"date":373,"type":34},"2026-01-21",{"date":375,"type":34},"2023-09-19",{"date":150,"type":22},{"name":378,"class":71},"The Cleveland Clinic",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":385,"maxAge":209,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":72},"100621157","is-there-a-benefit-from-addition-of-exercise-in-diabetic-patients-with-ed-who-complain-low-vitamin-d-100621157","NCT07366970","Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?","Inclusion Criteria:\n\n* diabetic men (forty)\n* type 2 diabetes\n* complaint of erectile dysfucntion (chronic complaint more than 24 months)\n* men with low vitamin D (deiciency in vitamin D)\n\nExclusion Criteria:\n\n* cardiac patients\n* respiratory disease patients\n* renal disease\n* liver disease","35 Years",{"count":187,"type":22},[25],"males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important",[390,29,391],"Diabetes Mellitus","Vitamin D Deficiency","2026-01-17",{"date":394,"type":34},"2026-01-26",{"date":396,"type":34},"2025-12-05",{"date":398,"type":22},"2026-05-05",{"name":400,"class":71},"Cairo University",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":410,"studyType":235,"phases":4,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":4},"100620360","primary-care-erectile-function-outcome-registry-for-men-100620360","NCT07356609","Primary Care ERectile Function Outcome Registry for Men","PERFORM","Inclusion Criteria:\n\n1. Adult male above 18 years of age\n2. Married\n3. Diabetic\n4. Patient reports erectile dysfunction (symptomatic).\n5. Patient is eligible to be prescribed sildenafil by treating clinician.\n\nExclusion Criteria:\n\n1. If at any other PDE-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil)\n2. Concurrent use of organic nitrates (any form: glyceryl trinitrate, isosorbide mononitrate\u002Fdinitrate) - absolute contraindication\n3. Recent or unstable cardiovascular disease\n\n   * Myocardial infarction or stroke in last 3 months\n   * Unstable angina\n   * Uncontrolled arrhythmia or heart failure NYHA III-IV\n   * Resting hypotension (SBP \\\u003C 90 mmHg) or uncontrolled hypertension (SBP \\> 180 mmHg) per treating clinician\n   * Known severe hepatic impairment or severe renal impairment on dialysis (if local clinician deems unsafe)\n   * Known hypersensitivity to sildenafil or excipients\n   * Concomitant use of potent CYP3A4 inhibitors (e.g., ritonavir) - unless clinician documents safe plan\u002Fdose adjustment",{"count":409,"type":22},255,"12 Months","The PERFORM registry is a structured, real-world data platform designed to systematically capture patient characteristics, disease severity and treatment patterns of Erectile Dysfunction (ED) across Pakistan. By reflecting routine clinical practice, an ED registry provides valuable insights into the disease epidemiology, unmet needs, and variations in care across populations. It supports evidence-based decision-making, helps identifying early predictors, and inform guideline development, health policy, and personalized management strategies in male sexual health.",[29],[118,414,415],"male reproductive health","male sexual health","2026-01-14",{"date":373,"type":34},{"date":419,"type":22},"2026-02-06",{"date":421,"type":22},"2027-05-31",{"name":423,"class":247},"Nabiqasim Industries (Pvt) Ltd",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":444,"locationsCount":72},"100410409","external-device-for-erectile-dysfunction-3d-erect-100410409","NCT04624126","External Device for Erectile Dysfunction (3D-Erect)","Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study","3D-Erect","Inclusion Criteria:\n\n* males \\>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and\u002For radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and\u002For metabolic ED etc.)\n* having a female partner willing to participate in the study.\n\nExclusion Criteria:\n\n* not willing to attempt sexual vaginal intercourse with their partner\n* inability to wear\u002Foperate the external penile device for any reason",{"count":433,"type":22},9,[25],"The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).",[29,437],"Impotentia Erigendi","2026-01-12",{"date":440,"type":34},"2026-01-13",{"date":442,"type":34},"2021-07-10",{"date":68,"type":22},{"name":445,"class":71},"Stanford University",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":72},"100521118","concurrent-low-intensity-shockwave-therapy-on-collagenase-clostridium-histolyticum-for-peyronies-disease-100521118","NCT06065436","Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease","Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial","Inclusion Criteria\n\n• Diagnosed with PD\n\n* Palpable penile plaque\n* Dorsal, lateral, or dorsolateral penile curvature\n* Penile curvature \\> 30 degrees and \\\u003C 90 degrees as measured using goniometer during objective curvature assessment\n* Non-calcified plaque or grade 1 calcification (\"stippling\", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)\n* \"Stable PD symptoms' defined as PD symptom duration \\> 6-months or stable symptoms \\> 3-months\n\nExclusion Criteria:\n\n* Prior intralesional injections or surgery for PD.\n* Severe baseline penile pain.\n* Moderate or severe baseline ED based on IIEF-EF domain.\n* History of low intensity shockwave therapy for sexual dysfunction (ED or PD).\n* Ventral (downward) or ventrolateral penile curvature.\n* Moderate or severe (grade 2\u002F3) plaque calcification as determined by PDDU.\n* Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.",{"count":454,"type":22},60,[25],"The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.",[458,29],"Peyronie Disease","2026-01-05",{"date":461,"type":34},"2026-01-07",{"date":463,"type":34},"2024-01-19",{"date":298,"type":22},{"name":466,"class":71},"Mayo Clinic",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":483,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":72},"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",{"count":476,"type":22},70,[141],"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.",[29,480,362,361,481,482],"Erectile Dysfunction Associated With Type 2 Diabetes Mellitus","Erectile Dysfunction Due to General Medical Condition","Erectile Dysfunction Due to Neuropathy",[29,484,485,473],"Exosome","Mesanchymal Stem Cell","2025-12-21",{"date":488,"type":34},"2026-01-06",{"date":490,"type":22},"2026-01",{"date":298,"type":22},{"name":493,"class":71},"Labbafinejad Medical Center",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":4},"100616878","phase-2-phase-iia-clinical-trial-of-yn001-in-patients-with-atherosclerotic-cardiovascular-and-cerebrovascular-diseases-and-erectile-dysfunction-100616878","NCT07311330","Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction","A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction","Inclusion Criteria:\n\n1. Fully understand the purpose, nature, method and possible adverse reactions of the study, voluntarily participate as a subject in the study, and sign the informed consent form (ICF) before performing any study-related assessments;\n2. One or both of the previous history of coronary atherosclerosis, coronary heart disease, cerebral atherosclerosis, stroke, ischemic attack, carotid atherosclerosis, peripheral arterial disease, or plaque in at least one vessel of the carotid, subclavian, or femoral arteries as detected by peripheral arterial ultrasound .\n3. Clinical diagnosis of mild to moderate erectile dysfunction, IIEF-5 questionnaire score ≤ 21 points, duration of at least 3 months (subject to signing informed consent);\n4. Subjects (including partners) guarantee that they have no plans to father a child or donate sperm during the study and for 3 months after the last dose and voluntarily take appropriate contraceptive measures;\n5. After the screening run-in period, the following three conditions were met simultaneously:\n\n1\\) At least 4 attempts at sexual intercourse during the run-in period; 2) Has a failure rate of ≥ 50% of attempts to intercourse (failure to intercourse is defined as having at least one of the three questions answered on the SEP); 3) IIEF-EF score ≥ 11 and ≤ 25.\n\nExclusion Criteria:\n\n1. Patients with erectile dysfunction caused by other sexual dysfunction diseases (such as ejaculatory dysfunction) or endocrine diseases that are not controlled (after medication) (such as hypogonadism, hyperthyroidism\u002Fhypothyroidism, pituitary tumor, etc.);\n2. History of stroke within 6 months prior to informed consent;\n3. Patients who have received or are receiving anti-androgen therapy, or have a history of androgen replacement therapy and are stable for less than 3 months;\n4. Patients scheduled for CABG, PCI, heart transplantation, SAVR\u002FTAVR during the study period;\n5. Patients with unstable diabetic blood glucose control, and fasting blood glucose more than 15 mmol\u002FL, or accompanied by diabetic complications (diabetic nephropathy, peripheral neuropathy);\n6. Combined with abnormal liver function, defined as AST and\u002For ALT more than 2 times the upper limit of normal;\n7. Combined with severe renal dysfunction, defined as glomerular filtration rate \\\u003C 30.0 mL\u002Fmin\u002F1.73m ² calculated by CKD-EPI formula;\n8. Subjects who have used vacuum aspiration (VCD), intracavernosal injection (ICI) therapy or other drugs to treat erectile dysfunction and cannot interrupt the above treatment during the study;\n9. Patients who have severe central nervous system injury (cerebral vascular diseases such as cerebral hemorrhage or ischemia, brain inflammatory diseases such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury), or peripheral nervous system injury or lesions within 6 months before signing the informed consent;\n10. History of myopathy\u002Fmyalgia, or susceptibility to myopathy\u002Frhabdomyolysis (e.g., family history of hereditary myopathy, previous use of HMG-CoA reductase inhibitors in combination with fibrates, etc.);\n11. Presenting with hypothyroidism, defined as marked TSH elevations (usually \\> 1.5 ULN) associated with decreases in free T4 (FT4) ;\n12. Patients with a history of drug abuse, drug abuse and alcoholism (tolerance, withdrawal, impaired control of drinking behavior) in the past 1 year;\n13. Participation in another interventional clinical investigator within 1 month prior to informed consent;\n14. Patients who, in the opinion of the investigator, are not suitable for this study.","75 Years",{"count":187,"type":22},[141],"This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction",[506,29],"Atherosclerotic Cardiovascular Disease (ASCVD)",{"date":508,"type":34},"2025-12-30",{"date":510,"type":22},"2026-01-31",{"date":512,"type":22},"2026-11-14",{"name":514,"class":247},"Beijing Inno Medicine Co., Ltd.",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100615268","phase-2-effect-of-moderate-alcohol-on-absorption-and-onset-of-hezkue-sildenafil-suspension-100615268","NCT07290400","Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension","Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension","Inclusion Criteria:\n\n* Male adults 21 to 65 years of age, inclusive\n* Documented history of erectile dysfunction for at least 6 months, as determined by the investigator\n* In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable\n* Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator\n* Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol\n* Willing to abstain from alcohol outside of protocol-specified intake during the study\n* Able to understand and provide written informed consent before any study-specific procedures are performed\n* Willing and able to comply with all study procedures, including dosing, washout periods, pharmacokinetic sampling, onset assessments, and safety monitoring\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation\n* Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period\n* Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension\n* Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator\n* Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments\n* History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol\n* History of alcohol use disorder, binge drinking, or other substance use disorder, as determined by the investigator\n* Positive urine drug screen or positive alcohol test at screening or admission (outside protocol-specified alcohol administration)\n* Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before first dosing unless approved by the investigator\n* Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV\n* Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives, whichever is longer\n* Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first dosing\n* Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable or interfere with study conduct or interpretation",{"count":523,"type":22},36,[141],"This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.",[29],"2025-12-16",{"date":529,"type":34},"2025-12-18",{"date":531,"type":22},"2026-04-15",{"date":533,"type":22},"2026-06-28",{"name":535,"class":247},"Aspargo Labs, Inc",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":80,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":548,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":72},"100601967","phase-1-hezkue-hezkue-turbo-and-commercial-sildenafil-products-in-fed-healthy-male-subject-100601967","NCT07117383","Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject","A Phase 1 Pharmacokinetic Study Comparing Hezkue® (ASP-001), Hezkue Turbo® (ASP-001.1), and Select Commercially Available Sildenafil Products Under Fed Conditions in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.\n* Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing.\n* Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.\n* Participant must have a creatinine clearance (CrCl) value greater than 80 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n* Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol.\n\nExclusion Criteria:\n\n* Unwilling or unable to comply with study procedures.\n* Use of any investigational drug (except Hezkue\u002FHezkue Turbo) within 30 days prior to dosing.\n* History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus.\n* Clinically significant abnormal lab results, vital signs, or ECGs.\n* Any hepatic impairment or abnormal liver function tests.\n* Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.\n* Clinically significant illness within 28 days prior to dosing.\n* Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).\n* History of significant food or drug allergies.\n* History of drug abuse within the past year or positive drug screen at screening.\n* Regular alcohol consumption exceeding 15 units per week.\n* Use of CYP450 enzyme inhibitors within 14 days prior to dosing.\n* Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.\n* Blood donation or significant blood loss within 3 months before screening.\n* Plasma donation within 14 days prior to first dose.\n* Inadequate venous access for repeated blood sampling.\n* Difficulty fasting or inability to consume standardized meals.\n* Intolerance to fatty foods or inability to consume a high-fat, high-calorie breakfast.\n* Difficulty swallowing.\n* Regular use of tobacco or nicotine products within 4 weeks prior to screening.\n* Major surgery within 3 months or minor surgery within 1 month before screening.\n* Considered unsuitable for study participation by the Investigator.\n* Institutionalized status.\n* Use of hormone replacement therapy within 6 months prior to dosing.\n* Consumption of Seville oranges, grapefruit, or pomelo within 7 days prior to dosing.\n* Consumption of caffeine, xanthine-containing products, or poppy seeds within 48 hours prior to dosing.\n* Receipt of a COVID-19 vaccine within 3 days prior to dosing.\n* Presence of braces, retainers, dentures, partial dentures, or tongue piercings.\n* Use of nitric oxide donors, organic nitrates\u002Fnitrites, antihypertensive medications, or PDE5 inhibitors within 14 days of dosing.\n* Blood pressure or heart rate outside acceptable ranges:\n\n  * Systolic BP \\\u003C90 or \\>140 mmHg\n  * Diastolic BP \\\u003C50 or \\>90 mmHg\n  * Heart rate \\\u003C50 or \\>100 bpm",{"count":544,"type":22},72,[189],"The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are:\n\nDo Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products?\n\nAre there any differences in safety or tolerability between the products?\n\nResearchers will compare multiple formulations to evaluate differences in drug absorption and side effects.",[29],[549,550,551,552],"erectile dysfunction","Viagra","sildenafil","tadalafil",{"date":554,"type":34},"2025-12-12",{"date":490,"type":22},{"date":557,"type":22},"2026-03",{"name":535,"class":247},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":272},"100483425","rigicon-infla10-three-piece-inflatable-penile-prosthesis-erase-ed-100483425","NCT05574868","Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)","Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction","ERASE-ED","Inclusion Criteria:\n\n1. Male ≥22 years of age.\n2. Diagnosed with erectile dysfunction (impotence).\n3. Agree to receive Infla10® three-piece IPP as an ED treatment.\n4. Willing to complete all protocol required follow-up visits and tests.\n\nExclusion Criteria:\n\n1. 1\\. Contraindication to general anesthesia.\n2. Known allergy or sensitivity to product materials as indicated in the device labeling.\n3. Previous penile prosthesis or prior enlargement surgeries\n4. Diagnosed penile sensory neuropathy.\n5. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.\n6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma\n7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation\n8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \\>300 or HbA1c ≥9.0 on morning of surgery)\n9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.\n10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.\n11. Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \\[serum creatinine \\> 2.0 mg\u002Fdl\\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.\n12. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.\n13. Lacking manual dexterity or mental abilities necessary to operate the device.\n14. Expected life expectancy \\\u003C two years.\n15. Unwilling or unable to sign the Informed Consent.\n16. Unwilling or unable to comply with the follow-up study requirements.\n17. Currently participating in an investigational drug or another investigational device exemption (IDE) study.\n18. Incarcerated subjects\n19. Psychogenic erectile dysfunction",{"count":568,"type":22},182,[25],"This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation.\n\nThis study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. )\n\nSubjects will be followed per protocol and institutional standard of care for ED and comorbidities.",[29],[573,574,575,29,576,577],"Infla10","Rigicon","Dynamic","Inflatable Penile Prosthesis","Penile Prosthesis","2025-12-03",{"date":396,"type":34},{"date":581,"type":34},"2022-07-11",{"date":583,"type":22},"2026-05-21",{"name":585,"class":247},"Rigicon, Inc.",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":598,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":603,"leadSponsor":604,"locationsCount":4},"100610715","phase-2-phase-2-efficacy-study-of-sildenafil-products-in-adult-men-with-erectile-dysfunction-100610715","NCT07231185","Phase 2 Efficacy Study of Sildenafil Products in Adult Men With Erectile Dysfunction","A Phase 2 Open-Label Study to Evaluate the Efficacy, Safety, and Treatment Experience of Hezkue® and Hezkue Turbo® Compared With Select Commercially Available Sildenafil Products in Adult Men With Erectile Dysfunction (ED)","Inclusion Criteria:\n\n* Male, 18 to 70 years of age.\n\nDocumented diagnosis of erectile dysfunction (ED) for at least 3 months, confirmed by a clinician.\n\nBaseline International Index of Erectile Function-Erectile Function (IIEF-EF) domain score ≤25.\n\nSexually active and attempting sexual intercourse at least 4 times per month during the 3 months prior to screening.\n\nWilling and able to attempt sexual intercourse at least once per week during the study.\n\nJudged by the Investigator to be in good general health other than ED.\n\nCreatinine clearance (CrCl) \\>80 mL\u002Fmin as calculated by Cockcroft-Gault.\n\nAble and willing to comply with all study procedures, including use of eDiary\u002FePRO tools and adherence to dosing instructions.\n\nExclusion Criteria:\n\n* Use of nitrates or nitric oxide donors in any form.\n\nUse of prohibited antihypertensive medications as defined in the protocol.\n\nUse of phosphodiesterase type 5 (PDE5) inhibitors within 5 days prior to baseline.\n\nUse of CYP450 inhibitors within 14 days prior to first dose.\n\nUse of CYP450 inducers or St. John's Wort within 28 days prior to first dose.\n\nUse of any prescription or non-prescription medications, herbal products, or dietary supplements not approved by the Investigator during the required restriction period.\n\nKnown hypersensitivity to sildenafil, tadalafil, vardenafil, peppermint oil, or any component of the investigational product.\n\nClinically significant abnormalities in screening laboratory tests, vital signs, or electrocardiograms, as judged by the Investigator.\n\nAny hepatic impairment or abnormal liver function test results at screening.\n\nPositive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nClinically significant illness within 30 days prior to the first dose.\n\nSignificant cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled hypertension, or severe arrhythmias.\n\nHistory of stroke or neurological disorder that may affect sexual function.\n\nSevere psychiatric disorder or substance abuse that may interfere with study participation.\n\nAnatomical penile deformity (such as Peyronie's disease) that may interfere with erectile function assessments.\n\nPositive urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine (PCP), or MDMA.\n\nAlcohol consumption exceeding 15 units per week.\n\nInitiation of new nicotine products during the study period.\n\nParticipation in another clinical trial (other than Hezkue\u002FHezkue Turbo studies) within 30 days prior to screening.\n\nBlood donation or significant blood loss within 3 months prior to screening, or plasma donation within 14 days prior to screening.\n\nMajor surgery within 3 months or minor surgery within 1 month before screening.\n\nConsumption of Seville oranges, grapefruit, or pomelo within 7 days before dosing.\n\nResting systolic blood pressure outside 90-140 mmHg, diastolic blood pressure outside 50-90 mmHg, or heart rate outside 50-100 beats per minute at screening.\n\nSexual partner is pregnant or unwilling to use effective contraception during the study.\n\nAny condition that, in the Investigator's opinion, would make the participant unsuitable for the study.\n\nInstitutionalized individuals.",{"count":594,"type":22},200,[141],"The goal of this clinical trial is to learn how different sildenafil-based erectile dysfunction (ED) treatments affect erectile function in adult men. The main questions it aims to answer are:\n\nDoes each assigned product improve erectile function over 12 weeks?\n\nWhat safety or tolerability issues occur when these products are used on an on-demand basis?\n\nResearchers will compare Hezkue® and Hezkue Turbo® with several commercially available sildenafil or sildenafil-plus-tadalafil products to see whether there are differences in effectiveness, treatment experience, or safety.\n\nParticipants will:\n\n* Use one assigned ED treatment on demand for 12 weeks\n* Complete electronic diaries and questionnaires about sexual-encounter outcomes and treatment satisfaction\n* Attend study visits for safety checks, laboratory tests, and assessments of erectile function",[29],[549,550,551],"2025-11-17",{"date":601,"type":34},"2025-11-19",{"date":490,"type":22},{"date":557,"type":22},{"name":535,"class":247},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":80,"sex":17,"minAge":612,"maxAge":50,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":618,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":72},"100583172","phase-1-the-objective-of-this-phase-1-study-is-to-evaluate-the-food-effect-of-100-mg-hezkue-turbo-asp-0011-sildenafil-under-fed-versus-100-mg-of-hezkue-turbo-asp-0011-sildenafil-under-fasted-conditions-in-healthy-adult-male-subjects-100583172","NCT06872866","The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects","A Phase 1 Food-Effect Study of 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* The participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.\n* Participants must be healthy male volunteers aged 20 to 70 years (inclusive) at the time of dosing.\n* Participants must have a body mass index between 18.0 and 29.9 kg\u002Fm² (inclusive) and a body weight of 50 to 100 kg (inclusive).\n* Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.\n* Participants must have a creatinine clearance (CrCl) value greater than 80 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n* Participants must agree to practice an acceptable method of contraception as outlined in the protocol.\n\nExclusion Criteria:\n\n* Unwillingness or inability to follow the procedures specified by the protocol.\n* Participant received any investigational drug\u002Fproduct within 30 days prior to the first dose.\n* History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus, or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the study.\n* Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator and\u002For designee.\n* Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and international normalized ratio during screening).\n* Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.\n* Reports a clinically significant illness during the 28 days prior to first dose (as determined by the Investigator and\u002For designee).\n* Subjects with known hypersensitivity to sildenafil or any component in the study medication, such as peppermint oil.\n* Reports a history of clinically significant allergies including food or drug allergies as judged by the Investigator.\n* History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates, Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and\u002For Day -1.\n* Regular alcohol consumption of \\>15 units per week, with one unit being equivalent to 330 mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positive alcohol breathalyzer test at screening and\u002For Day -1.\n* Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing.\n* Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing.\n* Use of prescription or non-prescription drugs, including individual vitamins, herbal and dietary supplements within seven days or five half-lives, whichever is longer, unless in the opinion of the Investigator and Sponsor's medical monitor the medication is not expected to interfere with the study procedures or compromise subject safety (occasional use of acetaminophen, naproxen, and ibuprofen are allowed).\n* Blood donation or significant blood loss within 3 months before screening. All volunteers will be advised not to donate blood for 30 days after completing the study.\n* Reports donating plasma within 14 days prior to first dose. All volunteers will be advised not to donate plasma for 30 days after completing the study.\n* Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).\n* Reports difficulty fasting or consuming standardized meals.\n* Reports intolerance to fatty foods or cannot consume a high-calorie and high-fat breakfast.\n* Subjects who have difficulty swallowing.\n* Regular use of tobacco (\\>4 cigarettes per day) or nicotine-containing products within four weeks before screening, or urinary cotinine level indicative of active smoking at screening and\u002For Day -1\n* Major surgery within three months or minor surgery within one month before screening as per the Principal Investigator (PI) judgment.\n* If, in the opinion of the PI, the subject is not suitable for the study.\n* Subject administered COVID-19 vaccine within three days prior to each check-in.\n* Subjects with retainers, braces, dentures, partial dentures, and\u002For tongue piercing.\n* Subjects using the following within 14 days of first dose:\n* Nitric oxide donors, such as organic nitrates or organic nitrites in any form\n* Antihypertensive medications\n* PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)\n\nSubjects with known hypertension or blood pressure and heart rate outside of the following ranges:\n\n* Systolic blood pressure: 90 - 140 mmHg\n* Diastolic blood pressure: 50 - 90 mmHg\n* Heart rate at screening: 50 - 100 beats per minute\n* Institutionalized volunteers.\n* Reports use of any hormone replacement therapy within 6 months prior to first dose.\n* Use of any products containing Seville oranges, grapefruit and pomelo within seven days prior to first dose and for the duration of the study.\n* Ingestion of any caffeine\u002Fxanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours prior to first dose and for the duration of the study.\n* Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study.","20 Years",{"count":614,"type":22},12,[189],"The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects",[29],[549,619,551],"viagra",{"date":601,"type":34},{"date":622,"type":34},"2025-04-15",{"date":624,"type":22},"2026-02-28",{"name":535,"class":247}]