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32528

Descrizione

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

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versioni (3)
  1. 06/11/18 06/11/18 -
  2. 06/11/18 06/11/18 -
  3. 06/11/18 06/11/18 -
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GlaxoSmithKline

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6 novembre 2018

DOI

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Creative Commons BY-NC 3.0
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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation

    Inglese

    Premature Ejaculation Disease History

    1 moduli  
    Premature Ejaculation Disease History
    Descrizione

    Premature Ejaculation Disease History

    Alias
    UMLS CUI-1
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI-2
    C0683519 (disease history)
    When did you first notice that you had premature ejaculation?
    Descrizione

    Premature Ejaculation; Notice

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    Have you had a health care practitioner provide you with a diagnosis of PE?
    Descrizione

    Premature Ejaculation; Diagnosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Date of diagnosis
    Descrizione

    Premature Ejaculation; Date of diagnosis

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C2316983 (Date of diagnosis)
    SNOMED
    432213005
    LOINC
    LP114957-6
    Have you ever used any medications, oral or topical in an attempt to control your PE?
    Descrizione

    Premature Ejaculation; Pharmaceutical Preparations

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    SSRI - Were you satisfied with the results?
    Descrizione

    Premature Ejaculation; Selective Serotonin Reuptake Inhibitors; Results

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0360105 (Selective Serotonin Reuptake Inhibitors)
    SNOMED
    373225007
    UMLS CUI [1,3]
    C1274040 (Result)
    SNOMED
    394617004
    Topical Anesthetic - Were you satisfied with the results?
    Descrizione

    Premature Ejaculation; Topical Anesthetic; Results

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0040464 (Topical anesthetic)
    SNOMED
    373520001
    UMLS CUI [1,3]
    C1274040 (Result)
    SNOMED
    394617004
    Other - Were you satisfied with the results?
    Descrizione

    Premature Ejaculation; Pharmaceutical Preparation, Other; Results

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038 (Premature Ejaculation)
    SNOMED
    44001008
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,4]
    C1274040 (Result)
    SNOMED
    394617004
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    Similar models

    Premature Ejaculation Disease History

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Premature Ejaculation Disease History
    C0033038 (UMLS CUI-1)
    C0683519 (UMLS CUI-2)
    Premature Ejaculation; Notice
    Item
    When did you first notice that you had premature ejaculation?
    date
    C0033038 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Premature Ejaculation; Diagnosis
    Item
    Have you had a health care practitioner provide you with a diagnosis of PE?
    boolean
    C0033038 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Premature Ejaculation; Date of diagnosis
    Item
    Date of diagnosis
    date
    C0033038 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Item
    Have you ever used any medications, oral or topical in an attempt to control your PE?
    text
    C0033038 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Premature Ejaculation; Pharmaceutical Preparations
    Code List
    Have you ever used any medications, oral or topical in an attempt to control your PE?
    CL Item
    No (No)
    CL Item
    Yes - SSRI (Yes - SSRI)
    CL Item
    Yes - Topical Anesthetic (Yes - Topical Anesthetic)
    CL Item
    Yes - Other (Yes - Other)
    Premature Ejaculation; Selective Serotonin Reuptake Inhibitors; Results
    Item
    SSRI - Were you satisfied with the results?
    boolean
    C0033038 (UMLS CUI [1,1])
    C0360105 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Premature Ejaculation; Topical Anesthetic; Results
    Item
    Topical Anesthetic - Were you satisfied with the results?
    boolean
    C0033038 (UMLS CUI [1,1])
    C0040464 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Premature Ejaculation; Pharmaceutical Preparation, Other; Results
    Item
    Other - Were you satisfied with the results?
    boolean
    C0033038 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
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