[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610715":3},{"organization":4,"armGroups":7,"interventions":60,"overallOfficials":113,"centralContacts":117,"locations":121,"responsibleParty":125,"collaborators":121,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":121,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":121,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":150,"whyStopped":121,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":121},{"fullName":5,"class":6},"Aspargo Labs, Inc","INDUSTRY",[8,14,19,25,30,35,40,45,50,55],{"label":9,"type":10,"description":11,"interventionNames":12},"Hezkue","EXPERIMENTAL","Participants receive Hezkue®, an oral liquid formulation of sildenafil, used on an on-demand basis for 12 weeks.",[13],"Drug: Hezkue",{"label":15,"type":10,"description":16,"interventionNames":17},"Hezkue Turbo","Participants receive Hezkue Turbo®, an oral liquid suspension delivering sildenafil via a metered-dose device, used on an on-demand basis for 12 weeks.",[18],"Drug: Hezkue Turbo",{"label":20,"type":21,"description":22,"interventionNames":23},"Galotam","ACTIVE_COMPARATOR","Participants receive Galotam®, a commercially available sildenafil product, used on an on-demand basis for 12 weeks.",[24],"Drug: Galotam",{"label":26,"type":21,"description":27,"interventionNames":28},"BlueChew","Participants receive BlueChew® sildenafil chewable tablets, used on an on-demand basis for 12 weeks.",[29],"Drug: BlueChew",{"label":31,"type":21,"description":32,"interventionNames":33},"Pfizer Viagra","Participants receive Pfizer Viagra®, a standard oral tablet formulation of sildenafil, used on an on-demand basis for 12 weeks.",[34],"Drug: Pfizer Viagra",{"label":36,"type":21,"description":37,"interventionNames":38},"Aristo Sildaristo","Participants receive Aristo Sildaristo®, a commercially available sildenafil tablet product, used on an on-demand basis for 12 weeks.",[39],"Drug: Aristo Sildaristo",{"label":41,"type":21,"description":42,"interventionNames":43},"Lemonaid Health Viagra","Participants receive Lemonaid Health-branded sildenafil (Viagra), used on an on-demand basis for 12 weeks.",[44],"Drug: Lemonaid Health Sildenafil",{"label":46,"type":21,"description":47,"interventionNames":48},"Ro Sparks","Participants receive Ro Sparks®, a combination sildenafil + tadalafil product, used on an on-demand basis for 12 weeks.",[49],"Drug: Ro Sparks",{"label":51,"type":21,"description":52,"interventionNames":53},"Hims Hard Mints","Participants receive Hims Hard Mints®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.",[54],"Drug: Hims Hard Mints",{"label":56,"type":21,"description":57,"interventionNames":58},"Hello Cake ED Cake Meds","Participants receive Hello Cake ED Cake Meds®, a combination sildenafil + tadalafil formulation, used on an on-demand basis for 12 weeks.",[59],"Drug: Hello Cake ED Cake Meds",[61,67,72,77,82,87,92,98,103,108],{"type":62,"name":9,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Hezkue® is an oral liquid formulation of sildenafil administered on an on-demand basis for the treatment period.",[9],[66],"Sildenafil oral spray",{"type":62,"name":15,"description":68,"armGroupLabels":69,"otherNames":70},"Hezkue Turbo® is an oral liquid suspension of sildenafil delivered via a metered-dose device, used on an on-demand basis.",[15],[71],"Sildenafil liquid suspension",{"type":62,"name":20,"description":73,"armGroupLabels":74,"otherNames":75},"Galotam® is a commercially available sildenafil product administered on an on-demand basis.",[20],[76],"Sildenafil tablet (Galotam)",{"type":62,"name":26,"description":78,"armGroupLabels":79,"otherNames":80},"BlueChew® sildenafil chewable tablets, used on an on-demand basis.",[26],[81],"Sildenafil chewable tablet",{"type":62,"name":31,"description":83,"armGroupLabels":84,"otherNames":85},"Pfizer Viagra® sildenafil tablets, administered on an on-demand basis.",[31],[86],"Sildenafil citrate",{"type":62,"name":36,"description":88,"armGroupLabels":89,"otherNames":90},"Aristo Sildaristo® is a commercially available sildenafil tablet product used on an on-demand basis.",[36],[91],"Sildenafil",{"type":62,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Lemonaid Health Sildenafil","Lemonaid Health-branded sildenafil tablets (Viagra equivalent), administered on an on-demand basis.",[41],[97],"Sildenafil (Lemonaid Health)",{"type":62,"name":46,"description":99,"armGroupLabels":100,"otherNames":101},"Ro Sparks® is a combination sildenafil + tadalafil product administered on an on-demand basis.",[46],[102],"Sildenafil + Tadalafil (Ro Sparks)",{"type":62,"name":51,"description":104,"armGroupLabels":105,"otherNames":106},"Hims Hard Mints® is a combination formulation containing sildenafil + tadalafil, used on an on-demand basis.",[51],[107],"Sildenafil + Tadalafil (Hims)",{"type":62,"name":56,"description":109,"armGroupLabels":110,"otherNames":111},"Hello Cake ED Cake Meds® is a combination sildenafil + tadalafil product administered on an on-demand basis.",[56],[112],"Sildenafil + Tadalafil (Hello Cake)",[114],{"name":115,"affiliation":5,"role":116},"Mario Guralnik, PhD","STUDY_DIRECTOR",[118,123],{"name":115,"role":119,"phone":120,"phoneExt":121,"email":122},"CONTACT","17189381157",null,"avi.berg@synergy-cro.com",{"name":124,"role":119,"phone":121,"phoneExt":121,"email":122},"Avi Berg",{"type":126,"investigatorFullName":121,"investigatorTitle":121,"investigatorAffiliation":121,"oldNameTitle":121,"oldOrganization":121},"SPONSOR","100610715","phase-2-phase-2-efficacy-study-of-sildenafil-products-in-adult-men-with-erectile-dysfunction-100610715",false,"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.","MALE","18 Years","70 Years",{"count":138,"type":139},200,"ESTIMATED","INTERVENTIONAL",[142],"PHASE2","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",[145],"Erectile Dysfunction",[147,148,149],"erectile dysfunction","Viagra","sildenafil","NOT_YET_RECRUITING","2025-11-17",{"date":153,"type":154},"2025-11-19","ACTUAL",{"date":156,"type":139},"2026-01",{"date":158,"type":139},"2026-03",{"name":5,"class":6}]