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ID

32186

Beschrijving

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Trefwoorden

  1. 23-10-18 23-10-18 -
  2. 14-01-19 14-01-19 -
  3. 04-03-19 04-03-19 -
Houder van rechten

GSK group of companies

Geüploaded op

23 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    Part 2: Treatment Period 1 - Physical Examination Form

    Administrative data
    Beschrijving

    Administrative data

    Subject Identifier
    Beschrijving

    Subject Identifier

    Datatype

    integer

    Physical Examination - Part 2 - Day 1
    Beschrijving

    Physical Examination - Part 2 - Day 1

    Indicate current physical findings by ticking the appropriate box(es) below
    Beschrijving

    if ABNORMAL, describe concisely: [different findings should be separated by either a (;) or (/)].

    Datatype

    text

    Date of Assessment
    Beschrijving

    Date of Assessment

    Datatype

    date

    Hair and Skin
    Beschrijving

    Hair and Skin

    Datatype

    text

    Lymph nodes
    Beschrijving

    Lymph nodes

    Datatype

    text

    Eyes
    Beschrijving

    Eyes

    Datatype

    text

    Ears, Nose, and Throat
    Beschrijving

    Ears, Nose, and Throat

    Datatype

    text

    Breasts
    Beschrijving

    Breasts

    Datatype

    text

    Respiratory
    Beschrijving

    Respiratory

    Datatype

    text

    Cardiovascular
    Beschrijving

    Cardiovascular

    Datatype

    text

    Abdomen
    Beschrijving

    Abdomen

    Datatype

    text

    Urogenital
    Beschrijving

    Urogenital

    Datatype

    text

    Pelvic
    Beschrijving

    Pelvic

    Datatype

    text

    Rectal
    Beschrijving

    Rectal

    Datatype

    text

    Musculoskeletal
    Beschrijving

    Musculoskeletal

    Datatype

    text

    Neurological
    Beschrijving

    Neurological

    Datatype

    text

    Mental Status
    Beschrijving

    Mental Status

    Datatype

    text

    Similar models

    Part 2: Treatment Period 1 - Physical Examination Form

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    Subject Identifier
    Item
    Subject Identifier
    integer
    Item Group
    Physical Examination - Part 2 - Day 1
    Indicate current physical findings by ticking the appropriate box(es) below
    Item
    Indicate current physical findings by ticking the appropriate box(es) below
    text
    Date of Assessment
    Item
    Date of Assessment
    date
    Item
    Hair and Skin
    text
    Code List
    Hair and Skin
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Lymph nodes
    text
    Code List
    Lymph nodes
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Eyes
    text
    Code List
    Eyes
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Ears, Nose, and Throat
    text
    Code List
    Ears, Nose, and Throat
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Breasts
    text
    Code List
    Breasts
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Item
    Respiratory
    text
    Code List
    Respiratory
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Cardiovascular
    text
    Code List
    Cardiovascular
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Abdomen
    text
    Code List
    Abdomen
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Urogenital
    text
    Code List
    Urogenital
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Item
    Pelvic
    text
    Code List
    Pelvic
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Item
    Rectal
    text
    Code List
    Rectal
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    CL Item
    Not Done (Not Done)
    Item
    Musculoskeletal
    text
    Code List
    Musculoskeletal
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Neurological
    text
    Code List
    Neurological
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    Item
    Mental Status
    text
    Code List
    Mental Status
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)

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