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

Primary Purpose

Ejaculation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dapoxetine
Sponsored by
Alza Corporation, DE, USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study participant's partner must have a negative pregnancy test at time of screening. Exclusion Criteria: History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra taking medications that are contraindicated for participation in the study currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally) previously participated in a drug study involving dapoxetine or in another drug trial within the last month taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 15, 2005
    Last Updated
    May 18, 2011
    Sponsor
    Alza Corporation, DE, USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00211107
    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 Study Of The Efficacy And Safety Of Dapoxetine HCl In The Treatment Of Rapid Ejaculation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alza Corporation, DE, USA

    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
    One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a randomized, double-blind study in men with PE. The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive dapoxetine at one of two dosages, or placebo, for use on an "as-needed" basis. The total duration of the study is approximately 14 weeks. Patients and their partners are expected to attempt sexual intercourse at least 4 times during the baseline period and at least 6 times each month during the treatment phase. Assessments of effectiveness include the average Intravaginal Ejaculatory Latency time (IELT), as measured by stopwatch, during sexual intercourse for the treatment period (12 weeks); 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 (12 weeks), vital sign measurements (pulse and blood pressure) and laboratory tests (hematology, chemistry, urinalysis) at monthly intervals. The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams[mg] or 60mg) taken as needed during 12 weeks of treatment. No more than one 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
    Ejaculation
    Keywords
    dapoxetine, rapid ejaculation, 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
    1294 (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, between last 2 visits during the treatment period
    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 and through Week 12; incidence, severity, and type of adverse events throughout study (12 weeks).

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study participant's partner must have a negative pregnancy test at time of screening. Exclusion Criteria: History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra taking medications that are contraindicated for participation in the study currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally) previously participated in a drug study involving dapoxetine or in another drug trial within the last month taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alza Corporation Clinical Trial
    Organizational Affiliation
    ALZA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16962882
    Citation
    Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006 Sep 9;368(9539):929-37. doi: 10.1016/S0140-6736(06)69373-2.
    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
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=105&filename=CR006088_CSR.pdf
    Description
    A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

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

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