ID

32029

Description

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

Keywords

Versions (3)
  1. 10/15/18 10/15/18 -
  2. 10/15/18 10/15/18 -
  3. 2/25/19 2/25/19 -
Copyright Holder

GSK group of companies

Uploaded on

October 15, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

English

Local Laboratory Results Data

1 forms  
Urinalysis
Description

Urinalysis

Date sample taken
Description

Date sample taken

Data type

date

Time sample taken
Description

Time sample taken

Data type

time

Laboratory Name
Description

Laboratory Name

Data type

text

Address
Description

Address

Data type

text

Lab ID
Description

For GSK use only

Data type

text

Result of dipstick
Description

Result of dipstick

Data type

text

Urinalysis (Dipstick) Test
Description

Urinalysis (Dipstick) Test

Data type

text

Specific gravity
Description

Specific gravity

Data type

text

Micro
Description

Micro

Data type

text

pH
Description

pH

Data type

text

Glucose
Description

Glucose

Data type

text

Protein
Description

Protein

Data type

text

Blood
Description

Blood

Data type

text

Ketones
Description

Ketones

Data type

text

Was sedimentary microscopy performed?
Description

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

Data type

boolean

WBC
Description

WBC

Data type

text

RBC
Description

RBC

Data type

text

Hyaline casts
Description

Hyaline casts

Data type

text

Granular casts
Description

Granular casts

Data type

text

Cellular casts
Description

Cellular casts

Data type

text

Randomisation Number
Description

Randomisation Number

Record randomisation number
Description

Record randomisation number

Data type

integer

Regimen
Description

Regimen

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

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

Data type

text

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

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

Data type

text

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Similar models

Local Laboratory Results Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Result of dipstick
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
Record below the treatment assignment for the subject participating in Part 1 of the study.
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
Complete only for subjects participating in PART 2 of the study
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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