ID

32028

Beskrivning

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

Nyckelord

  1. 2018-10-15 2018-10-15 -
  2. 2018-10-15 2018-10-15 -
  3. 2019-02-25 2019-02-25 -
Rättsinnehavare

GSK group of companies

Uppladdad den

15 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Local Laboratory Results Data

Urinalysis
Beskrivning

Urinalysis

Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Time sample taken
Beskrivning

Time sample taken

Datatyp

time

Laboratory Name
Beskrivning

Laboratory Name

Datatyp

text

Address
Beskrivning

Address

Datatyp

text

Lab ID
Beskrivning

For GSK use only

Datatyp

text

Result of dipstick
Beskrivning

Result of dipstick

Datatyp

text

Urinalysis (Dipstick) Test
Beskrivning

Urinalysis (Dipstick) Test

Datatyp

text

Specific gravity
Beskrivning

Specific gravity

Datatyp

text

Micro
Beskrivning

Micro

Datatyp

text

pH
Beskrivning

pH

Datatyp

text

Glucose
Beskrivning

Glucose

Datatyp

text

Protein
Beskrivning

Protein

Datatyp

text

Blood
Beskrivning

Blood

Datatyp

text

Ketones
Beskrivning

Ketones

Datatyp

text

Was sedimentary microscopy performed?
Beskrivning

NOTE: Sedimentary microscpy should only be performed if any of the dipstick results are abnormal.

Datatyp

boolean

WBC
Beskrivning

WBC

Datatyp

text

RBC
Beskrivning

RBC

Datatyp

text

Hyaline casts
Beskrivning

Hyaline casts

Datatyp

text

Granular casts
Beskrivning

Granular casts

Datatyp

text

Cellular casts
Beskrivning

Cellular casts

Datatyp

text

Randomisation Number
Beskrivning

Randomisation Number

Record randomisation number
Beskrivning

Record randomisation number

Datatyp

integer

Regimen
Beskrivning

Regimen

Complete only for subjects participating in PART 1 of the study.
Beskrivning

Record below the treatment assignment for the subject participating in Part 1 of the study Mark one

Datatyp

text

Complete only for subjects participating in PART 2 of the study
Beskrivning

Record below the treatment assignment for the subject participating in Part 2 of the study

Datatyp

text

Similar models

Local Laboratory Results Data

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Urinalysis
Date sample taken
Item
Date sample taken
date
Time sample taken
Item
Time sample taken
time
Laboratory Name
Item
Laboratory Name
text
Address
Item
Address
text
Lab ID
Item
Lab ID
text
Item
Result of dipstick
text
Code List
Result of dipstick
CL Item
[NEG] Negative (1)
CL Item
[POS] Positive -> If positive, record results of individual tests below. (2)
CL Item
[NR] No Result (3)
Urinalysis (Dipstick) Test
Item
Urinalysis (Dipstick) Test
text
Specific gravity
Item
Specific gravity
text
Micro
Item
Micro
text
pH
Item
pH
text
Glucose
Item
Glucose
text
Protein
Item
Protein
text
Blood
Item
Blood
text
Ketones
Item
Ketones
text
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
WBC
Item
WBC
text
RBC
Item
RBC
text
Hyaline casts
Item
Hyaline casts
text
Granular casts
Item
Granular casts
text
Cellular casts
Item
Cellular casts
text
Item Group
Randomisation Number
Record randomisation number
Item
Record randomisation number
integer
Item Group
Regimen
Item
Complete only for subjects participating in PART 1 of the study.
text
Code List
Complete only for subjects participating in PART 1 of the study.
CL Item
Part 1 Treatment Sequence 1 ([25])
CL Item
Part 1 Treatment Sequence 2 ([26])
CL Item
Part 1 Treatment Sequence 3 ([27])
CL Item
Part 1 Treatment Sequence 4 ([28])
CL Item
Part 1 Treatment Sequence 5 ([29])
CL Item
Part 1 Treatment Sequence 6 ([30])
Item
Complete only for subjects participating in PART 2 of the study
text
Code List
Complete only for subjects participating in PART 2 of the study
CL Item
Treatment D ([20])
CL Item
Treatment E ([21])
CL Item
Treatment F ([22])

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