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A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dapoxetine
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring dapoxetine, premature ejaculation, ejaculation, sexual dysfunction, orgasmic disorder, sexual intercourse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation history of intravaginal ejaculatory latency time (IELT) of <2 minutes in at least 3 out of 4 events good general health patient's partner must have a negative urine pregnancy test at time of screening Exclusion Criteria: Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months no history of any medical events that are associated with the development of PE not taken another investigational drug within 1 month, or used an experimental medical device within 6 months, of study initiation no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)

    Secondary Outcome Measures

    Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 24; incidence, severity, and type of adverse events throughout study and follow up (Week 27)

    Full Information

    First Posted
    September 27, 2005
    Last Updated
    June 6, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00229073
    Brief Title
    A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
    Official Title
    A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study Of The Efficacy And Safety Of Dapoxetine In The Treatment Of Subjects With Premature Ejaculation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).
    Detailed Description
    Premature ejaculation (PE) is a form of male sexual dysfunction. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a multicenter, placebo-controlled, double-blind, randomized, parallel-group study in men with PE. The study will consist 3 phases: pre-randomization phase (a screening visit and a 4-week baseline period); 24-week double-blind treatment phase during which patients will receive dapoxetine or placebo for use on an "as-needed" basis; and, 1-week double-blind withdrawal phase (dapoxetine or placebo) with a post-study telephone contact approximately 2 weeks after the end of treatment. The total duration of the study is approximately 31 weeks. Assessments of effectiveness include the average intravaginal ejaculatory latency time, as measured by stopwatch during sexual intercourse, during the treatment period; control over ejaculation, satisfaction with sexual intercourse, and severity of symptoms, based on questions asked at monthly intervals through the treatment phase. Safety assessments include the incidence, severity, and type of adverse events throughout treatment and follow up (Week 27), as well as laboratory tests and questionnaires to monitor possible changes in mood, anxiety, motor responses, and sexual function at specified times during the study. The study hypothesis is that treatment for 24 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams[mg] or 60mg) or placebo taken as needed during 24 weeks of treatment. No more than 1 dose within a 24-hour period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction
    Keywords
    dapoxetine, premature ejaculation, ejaculation, sexual dysfunction, orgasmic disorder, sexual intercourse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    1116 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dapoxetine
    Primary Outcome Measure Information:
    Title
    Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)
    Secondary Outcome Measure Information:
    Title
    Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 24; incidence, severity, and type of adverse events throughout study and follow up (Week 27)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation history of intravaginal ejaculatory latency time (IELT) of <2 minutes in at least 3 out of 4 events good general health patient's partner must have a negative urine pregnancy test at time of screening Exclusion Criteria: Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months no history of any medical events that are associated with the development of PE not taken another investigational drug within 1 month, or used an experimental medical device within 6 months, of study initiation no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19195772
    Citation
    Buvat J, Tesfaye F, Rothman M, Rivas DA, Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol. 2009 Apr;55(4):957-67. doi: 10.1016/j.eururo.2009.01.025. Epub 2009 Jan 21.
    Results Reference
    result
    PubMed Identifier
    21059176
    Citation
    McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.
    Results Reference
    derived
    PubMed Identifier
    20412423
    Citation
    Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010 Jun;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x. Epub 2010 Apr 19.
    Results Reference
    derived
    PubMed Identifier
    20367770
    Citation
    Althof SE, Brock GB, Rosen RC, Rowland DL, Aquilina JW, Rothman M, Tesfaye F, Bull S. Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation. J Sex Med. 2010 Jun;7(6):2243-2252. doi: 10.1111/j.1743-6109.2010.01793.x. Epub 2010 Mar 30.
    Results Reference
    derived
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=572&filename=CR004231_CSR.pdf
    Description
    A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Subjects With Premature Ejaculation

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