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ID

32533

Description

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

Keywords

Versions (3)
  1. 11/6/18 11/6/18 -
  2. 11/6/18 11/6/18 -
  3. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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License

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, 109059

    English

    Premature Ejaculation Disease History

    1 forms  
    Premature Ejaculation Disease History
    Description

    Premature Ejaculation Disease History

    Alias
    UMLS CUI-1
    C0033038
    UMLS CUI-2
    C0683519
    When did you first notice that you had premature ejaculation?
    Description

    Premature Ejaculation; Notice

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0574845
    Have you had a health care practitioner provide you with a diagnosis of PE?
    Description

    Premature Ejaculation; Diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0011900
    Date of diagnosis
    Description

    Premature Ejaculation; Date of diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C2316983
    Have you ever used any medications, oral or topical in an attempt to control your PE?
    Description

    Premature Ejaculation; Pharmaceutical Preparations

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0013227
    SSRI - Were you satisfied with the results?
    Description

    Premature Ejaculation; Selective Serotonin Reuptake Inhibitors; Results

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0360105
    UMLS CUI [1,3]
    C1274040
    Topical Anesthetic - Were you satisfied with the results?
    Description

    Premature Ejaculation; Topical Anesthetic; Results

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0040464
    UMLS CUI [1,3]
    C1274040
    Other - Were you satisfied with the results?
    Description

    Premature Ejaculation; Pharmaceutical Preparation, Other; Results

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033038
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C1274040
    Was the patient circumsized?
    Description

    Male Circumsizion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008819
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    Similar models

    Premature Ejaculation Disease History

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Male Circumsizion
    Item
    Was the patient circumsized?
    boolean
    C0008819 (UMLS CUI [1])
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