[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598167":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":61,"locations":67,"responsibleParty":82,"collaborators":43,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":43,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":110,"whyStopped":43,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14,20,25,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapoxetine Group:","EXPERIMENTAL","Dosage: 30 mg dapoxetine taken 1-3 hours before sexual activity (maximum 3 doses per week).\n\nDuration: 12 weeks.",[13],"Drug: serotonin reuptake inhibitor (SSRI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Dosage: Placebo tablet identical in appearance and taste to dapoxetine, following the same dosing protocol.\n\nDuration: 12 weeks.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Kegel Exercises Group","Protocol: Three sets of 10-15 pelvic floor muscle contractions daily, supervised by a physiotherapist.\n\nDuration: 12 weeks.",[24],"Behavioral: Exercise",{"label":26,"type":27,"description":28,"interventionNames":29},"Acupuncture Group","ACTIVE_COMPARATOR","Protocol: Two 30-minute sessions per week using standardized acupuncture points (e.g., CV4, SP6, ST36) by licensed acupuncturists.\n\nDuration: 12 weeks",[30],"Other: Acupuncture",{"label":32,"type":33,"description":34,"interventionNames":35},"Sham Acupuncture Group","SHAM_COMPARATOR","Protocol: Superficial needle application avoiding active acupuncture points, following the same frequency and duration.\n\nDuration: 12 weeks.",[36],"Other: Sham",[38,44,48,52,56],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","serotonin reuptake inhibitor (SSRI)","Dapoxetine Group\n\nDosage: 30 mg dapoxetine, taken orally 1-3 hours before anticipated sexual activity, with a maximum of 3 doses per week.\n\nAdministration: Provided in blister packs to ensure compliance. Reference: McMahon et al., 2011.",[9],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Placebo","Dosage: Placebo tablets identical in appearance and taste to dapoxetine, administered on the same schedule (1-3 hours before sexual activity, maximum 3 doses per week).\n\nAdministration: Provided in identical blister packs.",[15],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"Acupuncture","Protocol: Two 30-minute acupuncture sessions per week, targeting standardized points (e.g., CV4, SP6, ST36) known to influence sexual function and autonomic nervous system regulation.\n\nAdministration: Performed by licensed acupuncturists following a standardized protocol.\n\nReference: Sunay et al., 2011.",[26],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":43},"Sham","Sham Acupuncture Group:Protocol: Two 30-minute sessions per week using superficial needle insertion at non-active points to minimize therapeutic effects while maintaining the placebo effect.\n\nAdministration: Performed by licensed acupuncturists to ensure consistency with the active acupuncture group",[32],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":43},"BEHAVIORAL","Exercise","Kegel Exercises Group:Protocol: Participants will perform pelvic floor muscle exercises consisting of three sets of 10-15 contractions daily, each held for 5-10 seconds followed by relaxation.\n\nTraining: Participants will receive initial training from a licensed physiotherapist, with weekly follow-up sessions to ensure proper technique and adherence.\n\nReference: Pastore et al., 2014.",[21],[62],{"name":63,"role":64,"phone":65,"phoneExt":43,"email":66},"ALi İhsan Memmi","CONTACT","+90 5379220997","alimemmi@gmail.com",[68],{"facility":69,"status":43,"city":70,"state":43,"zip":43,"country":71,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Medipol","Istanbul","Turkey (Türkiye)",{"type":73,"coordinates":74},"Point",[75,76],28.94966,41.01384,{"lat":76,"lon":75},[79],{"name":80,"role":64,"phone":81,"phoneExt":43,"email":66},"ALi ihsan memmi","+90 537 922 0997",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Ali Ihsan Memmi","MD","100598167","comparison-of-the-efficacy-and-safety-of-dapoxetine-kegel-exercises-and-acupuncture-in-the-treatment-of-premature-ejaculation-a-randomized-double-blind-placebo-controlled-trial-100598167",false,"NCT07067970","Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Male, aged 18-50 years. Diagnosed with lifelong or acquired PE per ISSM criteria (IELT \\\u003C 2 minutes, lack of ejaculatory control, and associated distress or interpersonal difficulties).\n\nIn a stable sexual relationship with a partner for at least 6 months. Willing to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Presence of erectile dysfunction (diagnosed via International Index of Erectile Function score \\\u003C 21).\n\nSevere psychiatric disorders (e.g., major depression, bipolar disorder) or neurological conditions (e.g., multiple sclerosis, Parkinson's disease).\n\nCurrent use of selective serotonin reuptake inhibitors (SSRIs) or other psychotropic medications.\n\nHistory of alcohol or substance dependence. Known contraindications to dapoxetine (e.g., hepatic impairment) or acupuncture (e.g., bleeding disorders).\n\nPrevious pelvic floor surgery or trauma affecting pelvic floor muscles.","MALE","18 Years","60 Years",{"count":96,"type":97},250,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study aims to compare the efficacy and safety of dapoxetine, Kegel exercises, acupuncture, and their placebo controls in the treatment of premature ejaculation (PE). PE is a common male sexual dysfunction characterized by ejaculation occurring within one minute of vaginal penetration, causing distress or interpersonal difficulties (Althof et al., 2014). A total of 250 male participants will be randomized into five groups (dapoxetine, placebo, Kegel exercises, acupuncture, sham acupuncture) for a 12-week treatment period followed by a 4-week follow-up. The primary outcome is the increase in intravaginal ejaculation latency time (IELT), with secondary outcomes including the Premature Ejaculation Diagnostic Tool (PEDT) score, Sexual Quality of Life-Male (SQoL-M) score, and adverse effects.",[103],"Premature Ejaculation",[105,106,107,108,109],"premature ejaculation","acupuncture","dapoksetin","kegel","sham-acupuncture","NOT_YET_RECRUITING","2025-07-06",{"date":113,"type":114},"2025-07-16","ACTUAL",{"date":116,"type":97},"2025-10-01",{"date":118,"type":97},"2026-12-01",{"name":5,"class":6},1]