[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ryan Flannigan, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100638916",false,"NCT07601646","A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction","Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction","Inclusion Criteria:\n\n* Have had a confirmed clinical diagnosis of ED for more than three months based upon IIEF\n* Have failed PDE5 inhibitor therapy (inability to achieve an erection with adequate rigidity to allow penetrative sex)\n* Ability to take oral medication (sildenafil) and be willing to adhere to the study intervention regimen\n* Engaged in heterosexual relationship with partner for a minimum of 6 months\n\nExclusion Criteria:\n\n* History of unstable medical or psychiatric condition that, in the opinion of the principal investigator, could impact the patient's ability to complete the study investigations or protocol.\n* Spinal cord injury, or penile anatomical abnormalities\n* Cardiovascular conditions that prevent sexual activity (NYHA Class II or higher, any angina, or uncontrolled CHF or severe coronary artery disease)\n* History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study\n* Use of anti-androgens, or oral or injectable androgens\n* Documented hypotension or known orthostatic hypotension\n* Use of oral, topical or sublingual nitrates within 3 months prior to enrollment into the study\n* Hepatic (Child-Pugh Class C) or renal failure (eGFR \\\u003C 30)\n* Inadequate response to intracavernosal injection therapy previously\n* Peyronie's disease or Meatal stenosis","MALE","21 Years","75 Years",{"count":19,"type":20},83,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single arm dose escalation trial of a mucoadhesive intraurethral polymer suspension of alprostadil (ST-04) and will investigate the efficacy of 3 dose levels of ST-04 in adult males with a clinical diagnosis of Erectile Dysfunction (ED). This study aims to determine if ST-04, with or without sildenafil, will improve erectile function (EF) compared to baseline.\n\nParticipants in this study will receive ST-04, a new formulation containing the vasodilator, alprostadil which is known to be an effective drug in treating erectile dysfunction. ST-04 will be dispersed along the urethra, forming a hydrogel which adheres to the lining of the urethra with the goal of penile tumescence and erection. Participants may receive up to 3 dose level escalations of ST-04 over a 12-week period, for a total of up to 11 administrations of ST-04. Dose escalation may also be done with and without sildenafil.",[26,27,28],"Erectile Dysfunction (ED)","Erectile Dysfunctions","Erectile Function",[30,28,31,32],"Erectile Dysfunction","Alprostadil","Sildenafil","RECRUITING","2026-05-20",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":20},"2026-05",{"date":41,"type":20},"2027-05",{"name":43,"class":44},"Ryan Flannigan, MD","OTHER",""]