[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457106":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":67,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":30,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":30,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"RDC Clinical Pty Ltd","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Testofen 300mg","EXPERIMENTAL","Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.",[13],"Drug: Testofen 300mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Testofen 600mg","Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.",[18],"Drug: Testofen 600mg",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo comparator","PLACEBO_COMPARATOR","The placebo will consist of maltodextrin and will appear identical to the Testofen capsules. The placebo will be administered as per the active treatment - 2 capsules once daily for 12 weeks.",[24],"Drug: Placebo comparator",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.",[15],{"type":27,"name":20,"description":22,"armGroupLabels":35,"otherNames":30},[20],[37],{"name":38,"affiliation":39,"role":40},"Amanda Rao, PhD","RDC Clinical","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":30,"email":45},"CONTACT","+61 414 488 559","amanda@rdcglobal.com.au",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"David Briskey, PhD","+61 421 784 077","david@rdcglobal.com.au",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Brisbane","Queensland","4006","Australia","AU",{"type":59,"coordinates":60},"Point",[61,62],153.02809,-27.46794,{"lat":62,"lon":61},[65,66],{"name":38,"role":43,"phone":44,"phoneExt":30,"email":45},{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100457106","phase-3-effect-of-testofen-on-erectile-function-in-an-adult-male-population-100457106",false,"NCT05232279","Effect of Testofen on Erectile Function in an Adult Male Population","Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.","Inclusion Criteria:\n\n* Healthy male adults aged 40-75 years\n* Currently in a sexual relationship\n* Males with reduced erectile function (Score of \\\u003C25 on IIEF)\n* BMI ≤ 35\n* Able to provide informed consent\n* Agree not to change current diet and exercise program while enrolled in this trial\n* Agree not to undertake another clinical trial while enrolled in this trial\n\nExclusion Criteria:\n\n* History of prostate surgery and\u002For trauma\n* Receiving\u002Fprescribed treatment for erectile dysfunction, including oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories\n* Receiving\u002Fprescribed treatment to increase\u002Fdecrease testosterone levels e.g. androgens\u002Fanti androgens\n* Receiving\u002Fprescribed treatment to increase\u002Fdecrease nitrate or nitric oxide levels\n* Unstable or serious illness (e.g. serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, hormone production disorders)\\*\n* All current malignancies (excluding BCC) or chemotherapy and\u002For radiotherapy treatment for malignancy within the previous 2 years\n* Receiving\u002Fprescribed \\[e.g., Coumadin or Marevan (warfarin), heparin, dalteparin, enoxaparin) or other anticoagulation therapy (e.g., thromboembolectomy or the use of vena cava filters)\n* Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse\n* Chronic past and\u002For current alcohol use (\\>14 alcoholic drinks week)\n* Allergic to any of the ingredients in the active or placebo formula\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion\n* Participants who have participated in any other related clinical study during the past 1 month\n\na Any participant reporting having been told by their doctor that they have an under or over production of hormones (e.g., testosterone).\n\n\\*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and\u002For is burdensome in symptoms and\u002For treatments.","MALE","40 Years","75 Years",{"count":80,"type":81},120,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This is a double blind, randomised, placebo-controlled clinical study with a 12-week participation and 3 groups (2 active groups and 1 placebo group) designed to monitor erectile function symptom severity and the effect Testofen may have on improving erectile function, sexual function, and quality of life.",[87],"Erectile Dysfunction","2025-07-21",{"date":90,"type":91},"2025-07-24","ACTUAL",{"date":93,"type":91},"2022-04-19",{"date":95,"type":81},"2026-06",{"name":5,"class":6},1]