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ID

42182

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-11-11 2018-11-11 -
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 april 2021

DOI

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Licens

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

    Engelsk

    Eligibility Question

    1 Formulär  
    1. StudyEvent: ODM
      1. Eligibility Question
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
    Beskrivning

    Gender; Premature Ejaculation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0033038
    The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
    Beskrivning

    Sex behavior

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0036864
    The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
    Beskrivning

    Ejaculation, Resonse Latency, Time, Intravaginal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013746
    UMLS CUI [1,2]
    C0242465
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C0013746
    UMLS CUI [1,5]
    C0442122
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
    Beskrivning

    Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive, Enzyme-Linked Immunosorbent Assay

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149709
    UMLS CUI [2]
    C0281863
    UMLS CUI [3,1]
    C0920548
    UMLS CUI [3,2]
    C0014441
    Previous or Current Medical Conditions
    Beskrivning

    Previous or Current Medical Conditions

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0012634
    Erectile dysfunction (defined as IIEF-EF domain score <22)
    Beskrivning

    Erectile Dysfunction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0242350
    Abnormal Lab Values
    Beskrivning

    Abnormal Lab Values

    Alias
    UMLS CUI-1
    C0438215
    Subjects who have a serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory, when obtained in the morning versus in the afternoon, from screening lab which will need to be evaluated prior to randomization, if an afternoon lab is drawn and the subject meets exclusion criteria a repeat of an am lab is permitted to assess for inclusion in the trial.
    Beskrivning

    total serum testosterone measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2210797
    Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges when obtained from a screening lab which will need to be evaluated prior to randomization.
    Beskrivning

    Creatinine measurement, serum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Subject with a clinically significant elevation of AST of > 126 and/or ALT of > 144 when obtained from a screening lab which will need to be evaluated prior to randomization.
    Beskrivning

    Aspartate aminotransferase measurement; Alanine aminotransferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    Screening PSA value outside the country specific normal reference ranges.
    Beskrivning

    Prostate-Specific Antigen

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0138741
    TSH outside the country specific normal reference ranges at visit 1.
    Beskrivning

    Thyroid stimulating hormone measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0202230
    Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
    Beskrivning

    Free Triiodothyronine Assay

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0519160
    Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
    Beskrivning

    T4 free measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0202225
    Other exclusion criteria
    Beskrivning

    Other exclusion criteria

    Alias
    UMLS CUI-1
    C0680251
    UMLS CUI-2
    C0205394
    Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, and for the duration of the study.
    Beskrivning

    Grapefruit (food), Consumption of goods; Grapefruit juice, Consumption of goods; Fruit, Citrus, Consumption of goods

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0995150
    UMLS CUI [1,2]
    C0009830
    UMLS CUI [2,1]
    C0452456
    UMLS CUI [2,2]
    C0009830
    UMLS CUI [3,1]
    C0600183
    UMLS CUI [3,2]
    C0009830
    UMLS CUI [3,3]
    C0452453
    UMLS CUI [3,4]
    C0009830
    Tillbaka till toppen

    Similar models

    Eligibility Question

    1 Formulär
    1. StudyEvent: ODM
      1. Eligibility Question
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Gender; Premature Ejaculation
    Item
    Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
    boolean
    C0079399 (UMLS CUI [1])
    C0033038 (UMLS CUI [2])
    Sex behavior
    Item
    The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
    boolean
    C0036864 (UMLS CUI [1])
    Ejaculation, Resonse Latency, Time, Intravaginal
    Item
    The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
    boolean
    C0013746 (UMLS CUI [1,1])
    C0242465 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0013746 (UMLS CUI [1,4])
    C0442122 (UMLS CUI [1,5])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive, Enzyme-Linked Immunosorbent Assay
    Item
    A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
    boolean
    C0149709 (UMLS CUI [1])
    C0281863 (UMLS CUI [2])
    C0920548 (UMLS CUI [3,1])
    C0014441 (UMLS CUI [3,2])
    Item Group
    Previous or Current Medical Conditions
    C0262926 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    Erectile Dysfunction
    Item
    Erectile dysfunction (defined as IIEF-EF domain score <22)
    boolean
    C0242350 (UMLS CUI [1])
    Item Group
    Abnormal Lab Values
    C0438215 (UMLS CUI-1)
    total serum testosterone measurement
    Item
    Subjects who have a serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory, when obtained in the morning versus in the afternoon, from screening lab which will need to be evaluated prior to randomization, if an afternoon lab is drawn and the subject meets exclusion criteria a repeat of an am lab is permitted to assess for inclusion in the trial.
    boolean
    C2210797 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges when obtained from a screening lab which will need to be evaluated prior to randomization.
    boolean
    C0201976 (UMLS CUI [1])
    Aspartate aminotransferase measurement; Alanine aminotransferase measurement
    Item
    Subject with a clinically significant elevation of AST of > 126 and/or ALT of > 144 when obtained from a screening lab which will need to be evaluated prior to randomization.
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Prostate-Specific Antigen
    Item
    Screening PSA value outside the country specific normal reference ranges.
    boolean
    C0138741 (UMLS CUI [1])
    Thyroid stimulating hormone measurement
    Item
    TSH outside the country specific normal reference ranges at visit 1.
    boolean
    C0202230 (UMLS CUI [1])
    Free Triiodothyronine Assay
    Item
    Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
    boolean
    C0519160 (UMLS CUI [1])
    T4 free measurement
    Item
    Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
    boolean
    C0202225 (UMLS CUI [1])
    Item Group
    Other exclusion criteria
    C0680251 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Grapefruit (food), Consumption of goods; Grapefruit juice, Consumption of goods; Fruit, Citrus, Consumption of goods
    Item
    Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, and for the duration of the study.
    boolean
    C0995150 (UMLS CUI [1,1])
    C0009830 (UMLS CUI [1,2])
    C0452456 (UMLS CUI [2,1])
    C0009830 (UMLS CUI [2,2])
    C0600183 (UMLS CUI [3,1])
    C0009830 (UMLS CUI [3,2])
    C0452453 (UMLS CUI [3,3])
    C0009830 (UMLS CUI [3,4])
    Tillbaka till toppen 

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