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An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

Primary Purpose

Ejaculation, Erectile Dysfunction, Sexual Dysfunction

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

About this trial

This is an interventional treatment trial for Ejaculation focused on measuring Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  • Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
  • In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
  • Had a systolic blood pressure of <=180 mm Hg and a diastolic blood pressure <=100 mm Hg
  • Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria:
  • Currently taking any any protocol-defined prohibited medications
  • Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors
  • In the opinion of the Investigator is incapable of following the study schedule for any reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    001

    Arm Description

    dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months

    Outcomes

    Primary Outcome Measures

    Adverse events reported
    Results from physical examinations
    Results from vital signs measurements
    Results from clinical laboratory tests
    Results from ECGs

    Secondary Outcome Measures

    Results from patient reported outcomes (PRO) for perception of sexual functioning

    Full Information

    First Posted
    October 28, 2010
    Last Updated
    May 18, 2011
    Sponsor
    Alza Corporation, DE, USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01230762
    Brief Title
    An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
    Official Title
    An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alza Corporation, DE, USA

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
    Detailed Description
    This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ejaculation, Erectile Dysfunction, Sexual Dysfunction
    Keywords
    Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1774 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
    Intervention Type
    Drug
    Intervention Name(s)
    dapoxetine
    Intervention Description
    60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
    Primary Outcome Measure Information:
    Title
    Adverse events reported
    Time Frame
    Up to 9 months
    Title
    Results from physical examinations
    Time Frame
    Months 3 and 9 or termination visit
    Title
    Results from vital signs measurements
    Time Frame
    Months 1, 2 and 6
    Title
    Results from clinical laboratory tests
    Time Frame
    Months 1, 3, and 9 or termination visit
    Title
    Results from ECGs
    Time Frame
    At the 3 month visit and the 9 month visit/Termination Visit
    Secondary Outcome Measure Information:
    Title
    Results from patient reported outcomes (PRO) for perception of sexual functioning
    Time Frame
    During use of dapoxetine for up to 9 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013) In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment Had a systolic blood pressure of <=180 mm Hg and a diastolic blood pressure <=100 mm Hg Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria: Currently taking any any protocol-defined prohibited medications Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors In the opinion of the Investigator is incapable of following the study schedule for any reason
    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

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=95&filename=CR005041_CSR.pdf
    Description
    An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation.

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