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A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

Primary Purpose

Sexual Dysfunction, Ejaculation

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 Sexual Dysfunction focused on measuring dapoxetine, premature ejaculation, sexual dysfunction, orgasmic disorder, sexual intercourse, ejaculation

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 experience PE in the majority of sexual intercourse events good general health at study initiation patient and partner willing to avoid situations or activities that may have an effect o their sexual activity (for example, avoid pregnancy, refrain from any preplanned surgery) 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 such as surgery, injury, infections, or neurological conditions that are associated with the development of PE not taken an 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

    Incidence of withdrawal symptoms (defined by a checklist of signs and symptoms associated with stopping the therapy) at Weeks 9, 10, and 11 of treatment

    Secondary Outcome Measures

    Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study through Week 11; adverse incidence and severity throughout study and follow up (Week 12)

    Full Information

    First Posted
    September 13, 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
    NCT00210613
    Brief Title
    A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation
    Official Title
    A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal Effects of Chronic Daily and As-Needed Dosing With Dapoxetine in the Treatment of Premature Ejaculation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (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 assess the possible withdrawal effects after abruptly stopping daily therapy with dapoxetine compared with continuing daily therapy in men with premature ejaculation (PE).
    Detailed Description
    Premature ejaculation (PE) is a form of male sexual dysfunction. A measure of withdrawal effects associated with stopping therapy for PE is the Discontinuation-Emergent Signs and Symptoms (DESS), a series of questions for signs and symptoms experienced by the patient. This study of men with PE is a multicenter, randomized, double-blind trial consisting of 3 phases: pre-randomization phase (a screening visit and 1-week baseline period); 10-week double-blind treatment phase during which patients receive dapoxetine or placebo; and 2-week follow-up phase. The total duration of the study is approximately 13 weeks. During the double-blind phase patients receive study medication for once daily treatment and for use on as "as-needed" basis prior to sexual activity. After 9 weeks, some patients (half of the active patients) continue treatment with dapoxetine and other (another half of the active patients) are switched to placebo for the last week of therapy, abruptly stopping the study drug. Assessments of effectiveness include the incidence of withdrawal symptoms, assessed by changes in DESS; control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at specified intervals during the study. Safety assessments include the incidence, severity, and type of adverse events throughout the study, as well as laboratory tests and questionnaires to monitor sexual function at specified times during the study.The study hypothesis is that abruptly stopping treatment with dapoxetine in men with PE does not result in an increase in withdrawal symptoms (as assessed by DESS), compared with the men who stay with the treatment. Oral tablets of dapoxetine (60 milligrams) taken once daily and also as needed during 10 weeks of treatment. No more than 1 tablet for daily treatment and 1 as-needed tablet within a 24-hour period.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Dapoxetine
    Primary Outcome Measure Information:
    Title
    Incidence of withdrawal symptoms (defined by a checklist of signs and symptoms associated with stopping the therapy) at Weeks 9, 10, and 11 of treatment
    Secondary Outcome Measure Information:
    Title
    Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study through Week 11; adverse incidence and severity throughout study and follow up (Week 12)

    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 experience PE in the majority of sexual intercourse events good general health at study initiation patient and partner willing to avoid situations or activities that may have an effect o their sexual activity (for example, avoid pregnancy, refrain from any preplanned surgery) 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 such as surgery, injury, infections, or neurological conditions that are associated with the development of PE not taken an 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
    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
    background
    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
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=529&filename=CR003451_CSR.pdf
    Description
    A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal Effects of Chronic Daily and As-Needed Dosing With Dapoxetine in the Treatment of Premature Ejaculation.

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    A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

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