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    Summary
    EudraCT Number:2004-002700-16
    Sponsor's Protocol Code Number:R096769-PRE-3001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2004-002700-16
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Subjects With Premature Ejaculation
    A.3.2Name or abbreviated title of the trial where available
    Study of Dapoxetine in the Treatment of Subjects With Premature Ejaculation
    A.4.1Sponsor's protocol code numberR096769-PRE-3001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedapoxetine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedapoxetine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature Ejaculation (PE)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that dapoxetine (30 or 60 mg prn) can prolong intravaginal ejaculatory latency time (IELT) as measured by stopwatch when compared to placebo in men with PE during the 24-week treatment phase
    E.2.2Secondary objectives of the trial
    To assess patient-reported outcomes in subjects receiving dapoxetine compared to those in subjects receiving placebo
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Males 18 years and older, 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.

    Subjects must, by reported history, meet the following diagnostic criteria for PE as specified in the DSM-IV-TR for at least 6 months before enrolling in the study, specifically:
    - the onset of orgasm and ejaculation occurs with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it
    - PE in the majority of intercourse experiences
    - PE must cause at least distress or interpersonal difficulty, as defined by a subject's response to "Personal Distress" and "Relationship Distress" questions in the Ejaculation Questionnaire. To be eligible to participate in the study a subject must define distress level as at least "moderately distressed" for at least 1 of these questions
    - PE must not be exclusively due to the direct effects of a substance (e.g., withdrawal from opioids)

    Has a qualifying IELT according to the Baseline Event Log (reviewed at baseline before the first dose of study drug), which is defined as follows:
    - an IELT of <= 2 minutes in a minimum of 3 out of 4 evaluable events (if more than 4 evaluable events have been recorded in the Baseline Event Log, a minimum of 75% of evaluable events must have an IELT <= 2 minutes)
    - an evaluable event is one for which the subject or his partner has indicated "prior to vaginal penetration" or "intravaginal" under the "Ejaculation Occurred" field on the Baseline Event Log and for which at least 20 hours have passed since the subject's last ejaculation

    Must be in good general health before study participation with no clinically relevant abnormalities as determined by: medical history, physical examination, blood chemistry, complete blood count, urinalysis, and 12-lead ECG

    Subject's and partners are willing to follow the recommendation to avoid situations/activities that may have an affect on their sexual activity (e.g., avoid pregnancy, refrain from any preplanned surgery)

    Subject's partner must have a negative urine pregnancy test at screening as pregnancy might affect sexual activity

    Subjects and partners must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate

    Subjects must have signed the informed consent for genetic testing indicating whether they do or do not wish to participate in the genetic part of the study; participation in the genetic testing component is not mandatory for participation in the study
    E.4Principal exclusion criteria
    Has received study drug in prior dapoxetine trials or has participated in another study within the past 3 months investigating pharmacologic treatment of PE

    Significant history of or current cardiovascular (including cardiac synkope), pulmonary, gastrointestinal, hematologic, neurologic (including seizure disorders), locomotor, immunologic, ophthalmologic, metabolic, endocrine, thromboembolic (including history of pulmonary embolism), rheumatologic, oncologic, renal, or hepatic disorders. Subjects with a history of hypertension (inlcuding newly diagnosed hypertension) must be adequately treated on a stable antihypertensive medical regimen for at least 4 weeks before screening.

    Subjects with either a blood pressure of >= 180mmHg systolic or >= 100mmHG diastolic both at screening (Visit 1) and at the end of the baseline period (Visit 2), or a pulse rate of >= 100 beats per minute at Visits 1 and 2 should be excluded form enrollment.

    Has a history of any medical events such as surgical interventions (e.g., pelvic/retroperitoneal surgery), neurological conditions (e.g., multiple sclerosis), trauma (e.g., spinal cord injury), or infections (e.g., chronic prostatitis) that were associated with the onset of PE symptoms and considered a potential cause of PE

    Has taken an investigational drug within 1 month of the screening visit or within a period of less than 5 times the drugs half-life, whichever is longer or used an experimental medical device within 6 months of the screening visit

    Has taken disallowed medication and has not completed the required washout period (Attachment 1, Washout Requirements for Selected Medications/Treatments)

    Positive diagnosis of depressive or anxiety disorder, dysthymia, suicidality, (hypo) manic episode, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, non-alcohol psychoactive substance use disorder, or psychotic disorders based on the Mini International Neuropsychiatric Interview (M.I.N.I.)

    Has a history of drug abuse within the past 2 years

    Has a history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism. Subjects meeting DSM-IV-TR diagnosis for a current depressive or anxiety disorder, or subjects who received any treatment (pharmacotherapy and/or psychotherapy) for a depressive or anxiety disorder within the past 2 years, must also be excluded. (Subjects who report anxiety primarily centering on sexual performance/PE may be included)

    Has significant problems with other forms of sexual dysfunction, such as decreased interest in sexual intercourse inhibited or absent orgasm or ejaculation, and erectile dysfunction (ED)

    Currently receiving treatment for ED or has a score of <21 in the Erectile Function Domain of the International Index of Erectile Function Questionnaire (IIEF, Questions 1 through 5 and 15)

    History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C

    Subjects with hyperprolactinemia or untreated or insufficiently treated hypothyroidism

    Has a known allergy or hypersensitivity to SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs)

    Any significant condition that, in the opinion of the investigator, could interfere with the subject's or their partner's participation or compliance in the study
    E.5 End points
    E.5.1Primary end point(s)
    Average IELT at the end of the double-blind treatment phase
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Information not present in EudraCT
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 1300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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