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    Summary
    EudraCT Number:2004-000244-24
    Sponsor's Protocol Code Number:A3871027
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-03
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-000244-24
    A.3Full title of the trial
    A Phase 2b, multi-center, double-blind, placebo-controlled, parallel group dose response study to assess the efficacy and safety of oral UK-390,957 in men with premature ejaculation.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA3871027
    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 SponsorPfizer Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 nameN/A
    D.3.2Product code UK_390,957-18
    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.3.11 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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature Ejaculation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10036596
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to model the dose response of UK-390,957 at week 8 and to define the least effective dose in the ≤2 minutes population, based on Intervaginal Ejaculatory Latency Time as the primary endpoint.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of the study are to demonstrate the superiority of one or more doses of UK-390,957 versus placebo at Week 8 in the IELT response in the ≤2 minutes population and to model the dose response of UK-390,957 at Week 8 and to define the least effective dose in the ≤1 minute population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Subject is an adult male ≥ 18 years of age
    2) Subject has provided written informed consent before screening
    3) Subject meets the diagnostic criteria for PE as specified in DSM-IV-TR™ for at least the last 6 months (Appendix E)
    4) Subject has a stable, monogamous, heterosexual relationship & sexually active for at least the last 6 months
    5) Subject and his female partner are willing to engage in at least 4 attempts at sexual intercourse between clinic Visits (Screening to Baseline, Baseline to Visit 3, Visit 3 to Visit 4 and Visit 4 to Visit 5)
    6) Subject has recorded in the electronic diary at least 4 intravaginal penetrations, during the run-in period i.e. between the screening visit (Visit 1) and the baseline visit (Visit 2), of which at least 70% show an intravaginal ejaculatory latency time (IELT) of less than or equal to 2 minutes. The 70% of occasions will be calculated as the 70th percentile of the IELTs in the run-in period
    E.4Principal exclusion criteria
    1) Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e. always ejaculates prior to penetration)
    2) Subject has other forms of ejaculatory dysfunction (e.g. retrograde ejaculation, anejaculation, painful ejaculation)
    3) Subject has a urinary tract infection. Subjects with a positive leukocyte esterase or nitrate test on dipstick testing, must have a urinary tract infection (UTI) ruled out prior to randomization. Subjects found to have a UTI must be treated before being rescreened
    4) Subject has a history of erectile dysfunction (ED), or is currently receiving treatment for ED or has a score of <22 on the Erectile Function Domain Score (Appendix L)
    5) Subject has other sexual disorders such as hypoactive sexual desire disorder and inhibited or absent orgasm
    6) Subject has any other condition, psychiatric, medical (e.g. prostatitis or urethritis) or surgical (e.g. non-retractable foreskin), that in the investigator’s judgment may impact the subject’s ejaculatory function
    7) Subject is unwilling to stop for the duration of the study any method of delaying ejaculation, such as: a) Use of multiple condoms or those condoms specifically marketed for the purpose of decreasing penile sensitivity. (The use of single condoms for contraceptive purposes is permitted) b) Engaging in masturbation (stimulation) to ejaculation in the period prior to sexual intercourse c) Pause-squeeze technique or other forms of behavioral therapy d) Counseling or psychotherapy (specifically for this purpose) e) Use of alcohol or any other substance (specifically for this purpose) f) Any penile rings/desensitizing bands
    8) In the 2 weeks prior to the screening visit, subject has used any treatment including devices, oral agents (e.g. SSRIs, tricyclic antidepressants, major tranquilizers, anxiolytics, alpha blockers, PDE-5 inhibitors, herbal treatments or other over-the-counter remedies), topical agents (e.g. anesthetic creams/sprays), or injection therapies for PE
    9) Subject currently or within the past 12 months has required any form of treatment for depression (includes counseling/psychotherapy) or has a past medical history of mania, hypomania or bipolar disorder
    10) In the 2 weeks prior to the screening visit, subject has received SSRIs, tricyclic antidepressants, tryptophan, lithium or St John’s Wort for any reason
    11) In the 2 weeks prior to screening, subject has received a drug known to have significant interactions with SSRIs. These include but are not limited to: Anticoagulants, reversible inhibitors of monoamine oxidase type A (RIMAs), irreversible monoamine oxidase inhibitors (MAOIs) for any reason
    12) Subject has a condition for which use of SSRIs is contraindicated or cautioned, such as: a) history of narrow angle glaucoma b) history of uncontrolled epilepsy c) history of bleeding disorders d) clinically significant (severe) renal or hepatic impairment.
    13) Subject has any clinically significant abnormalities on screening physical examination, ECG, or safety laboratory tests (e.g. significant hematuria). Inclusion of subjects with abnormalities of doubtful significance must be discussed with the Pfizer representative prior to enrollment
    14) Subject has received an experimental, non-approved drug within the past 3 months
    15) Subject has a history of severe drug allergies or hypersensitivity or multiple adverse drug reactions
    16) Subject intends to donate blood or blood products during the period of the study or within 1 month of the study’s completion
    17) Subject has a history of drug abuse within the past 2 years
    18) Subject has any medical or psychological condition or social circumstances that would impair his ability to participate reliably in the study
    19) Subject who in the investigator’s judgment is not a suitable candidate for this study for whatever reason
    20) Subject has been previously randomized to any other clinical trial with UK- 390,957
    E.5 End points
    E.5.1Primary end point(s)
    Intravaginal ejaculatory latency time (IELT) as measured by the timer at week 8
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Last patient last visit, plus 2 week follow-up visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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) No
    F.2 Gender
    F.2.1Female No
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 460
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As specified in the protocol
    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 Decision2004-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-06-03
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