[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457106":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":49,"interventions":67,"overallOfficials":77,"centralContacts":82,"locations":91,"responsibleParty":108,"collaborators":39,"id":110,"slug":39,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":39,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":39,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":39,"overallStatus":93,"whyStopped":39,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"RDC Clinical Pty Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in International Index of Erectile Function (IIEF) questionnaire","The IIEF is a self-administered questionnaire in which participants will be asked to answer 15 questions relating to erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction. Lower scores indicated higher perceived erectile dysfunction","Baseline prior to commencement of study product, Week 4, Week 8 and Week 12",{"measure":14,"description":15,"timeFrame":12},"Change in Erection Hardness Score (EHS)","Participants will be required to assess their erection quality by using the EHS. They will be asked to rate the hardness of their erection on a scale of one to four, with four being the maximal score.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"Change in the Ageing Male Symptom (AMS) Questionnaire","The Ageing Males' Symptoms scale (AMS) is a self-administered questionnaire that will help assess the symptoms of ageing, often related to androgen decline. As the men in this population are aged between 40 and 75 years, this questionnaire will be used to assess any changes in quality of life.","Baseline prior to commencement of study product and Week 12",{"measure":22,"description":23,"timeFrame":20},"Change in Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)","The DISF-SR is composed of 25 items and examines different aspects of human sexual functioning including sexual cognition and fantasy, sexual arousal, sexual behaviour and experiences, orgasm, and sexual drive and relationship.",{"measure":25,"description":26,"timeFrame":20},"Change in cardiovascular health","Blood pressure (BP) as measured by automatic blood pressure machine",{"measure":28,"description":29,"timeFrame":20},"Change in cardiovascular circulation","Doppler flow cytometry of the Femoral artery to assess circulation",{"measure":31,"description":32,"timeFrame":20},"Change in height in anthropometry measurements","Height as measured by stadiometer in centimeters",{"measure":34,"description":35,"timeFrame":20},"Change in weight in anthropometry measurements","Weight as measured by digital scales in kilograms",{"measure":37,"description":38,"timeFrame":20},"Change in waist circumference in anthropometry measurements","Waist circumference as measured by tape in centimeters",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":46},"DOUBLE",[47,48],"PARTICIPANT","INVESTIGATOR",[50,56,61],{"label":51,"type":52,"description":53,"interventionNames":54},"Testofen 300mg","EXPERIMENTAL","Testofen in capsule form - taken as a 300mg dosage (2 capsules) once daily for 12 weeks.",[55],"Drug: Testofen 300mg",{"label":57,"type":52,"description":58,"interventionNames":59},"Testofen 600mg","Testofen in capsule form - taken as a 600mg dosage (2 capsules) once daily for 12 weeks.",[60],"Drug: Testofen 600mg",{"label":62,"type":63,"description":64,"interventionNames":65},"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.",[66],"Drug: Placebo comparator",[68,72,75],{"type":69,"name":51,"description":70,"armGroupLabels":71,"otherNames":39},"DRUG","Testofen in capsule form - To be taken as a 300mg dosage (2 capsules) once daily for 12 weeks.",[51],{"type":69,"name":57,"description":73,"armGroupLabels":74,"otherNames":39},"Testofen in capsule form - To be taken as a 600mg dosage (2 capsules) once daily for 12 weeks.",[57],{"type":69,"name":62,"description":64,"armGroupLabels":76,"otherNames":39},[62],[78],{"name":79,"affiliation":80,"role":81},"Amanda Rao, PhD","RDC Clinical","PRINCIPAL_INVESTIGATOR",[83,87],{"name":79,"role":84,"phone":85,"phoneExt":39,"email":86},"CONTACT","+61 414 488 559","amanda@rdcglobal.com.au",{"name":88,"role":84,"phone":89,"phoneExt":39,"email":90},"David Briskey, PhD","+61 421 784 077","david@rdcglobal.com.au",[92],{"facility":5,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"RECRUITING","Brisbane","Queensland","4006","Australia","AU",{"type":100,"coordinates":101},"Point",[102,103],153.02809,-27.46794,{"lat":103,"lon":102},[106,107],{"name":79,"role":84,"phone":85,"phoneExt":39,"email":86},{"name":88,"role":84,"phone":89,"phoneExt":39,"email":90},{"type":109,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","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":120,"type":121},120,"ESTIMATED","INTERVENTIONAL",[124],"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.",[127],"Erectile Dysfunction","2025-07-21",{"date":130,"type":131},"2025-07-24","ACTUAL",{"date":133,"type":131},"2022-04-19",{"date":135,"type":121},"2026-06",{"name":5,"class":6},1]