[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638916":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":46,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm Dose Escalation","EXPERIMENTAL","Dose Level 1 is 500 μg of ST-04; Dose Level 2 is 1000 μg of ST-04 with or without Sildenafil; Dose Level 3 is 1500 μg of ST-04 with or without Sildenafil.",[13],"Drug: ST-04",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ST-04","ST-04 consists of an alprostadil polymer suspension designed for intraurethral application",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Vancouver Prostate Centre","RECRUITING","Vancouver","British Columbia","V5Z1M9","Canada","CA",{"type":31,"coordinates":32},"Point",[33,34],-123.11934,49.24966,{"lat":34,"lon":33},[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Genevive - Clinical Trials Coordinator","CONTACT","604-875-4111","67898","clinicaltrials@prostatecentre.com",{"name":44,"role":45,"phone":20,"phoneExt":20,"email":20},"Ryan Flannigan, MD","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":44,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Director of Male Reproduction & Sexual Medicine Research Program, Department of Urologic Sciences","100638916","phase-2-a-single-arm-dose-escalation-of-an-intraurethral-alprostadil-paste-for-erectile-dysfunction-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":60,"type":61},83,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67,68,69],"Erectile Dysfunction (ED)","Erectile Dysfunctions","Erectile Function",[71,69,72,73],"Erectile Dysfunction","Alprostadil","Sildenafil","2026-05-20",{"date":76,"type":77},"2026-05-22","ACTUAL",{"date":79,"type":61},"2026-05",{"date":81,"type":61},"2027-05",{"name":44,"class":6},1]