[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369056":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":46,"centralContacts":36,"locations":51,"responsibleParty":64,"collaborators":36,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":36,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":88,"whyStopped":36,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sohag University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.",[13],"Drug: Multi-Vitamin Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Dapoxetine","ACTIVE_COMPARATOR","Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.",[19],"Drug: Dapoxetine",{"label":21,"type":16,"description":22,"interventionNames":23},"Dapoxetine and folic acid.","Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.",[24],"Drug: Dapoxetine and folic acid.",{"label":26,"type":16,"description":27,"interventionNames":28},"Dapoxetine and vitamin B12","Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12",[29],"Drug: Dapoxetine and vitamin B12",[31,37,40,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Multi-Vitamin Tablets","The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.",[9],null,{"type":32,"name":15,"description":38,"armGroupLabels":39,"otherNames":36},"The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.",[15],{"type":32,"name":21,"description":41,"armGroupLabels":42,"otherNames":36},"The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.",[21],{"type":32,"name":26,"description":44,"armGroupLabels":45,"otherNames":36},"The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12",[26],[47],{"name":48,"affiliation":49,"role":50},"Mohammed Abu El-Hamd, MD","Assistant Professor","PRINCIPAL_INVESTIGATOR",[52],{"facility":53,"status":36,"city":54,"state":36,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":36},"Faculty of Medicine, Sohag University, Egypt","Sohag","82524","Egypt","EG",{"type":59,"coordinates":60},"Point",[61,62],31.69478,26.55695,{"lat":62,"lon":61},{"type":50,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Mohammed Abu El-Hamd","Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.","100369056","phase-3-evaluation-of-the-clinical-efficacy-and-safety-of-dapoxetine-combined-dapoxetine-with-folic-acid-and-combined-dapoxetine-with-vitamin-b12-in-treatment-of-patients-with-premature-ejaculation-100369056",false,"NCT04085354","Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation","Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial","PE","Inclusion Criteria:\n\nPremature ejaculation\n\nExclusion Criteria:\n\n* Erectile dysfunction\n* Diabetes mellitus\n* chronic prostatitis\n* Advanced renal or hepatic diseases\n* Neurological diseases","MALE","20 Years","50 Years",{"count":79,"type":80},120,"ACTUAL","INTERVENTIONAL",[83],"PHASE3","This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.",[86],"Premature Ejaculation",[86],"COMPLETED","2019-09-07",{"date":91,"type":80},"2019-09-11",{"date":93,"type":80},"2019-02-10",{"date":95,"type":80},"2019-08-29",{"name":5,"class":6},1]