ID

32267

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. 10/25/18 10/25/18 -
  2. 1/17/19 1/17/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GSK group of companies

Uploaded on

October 25, 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

Part 2: Repeat Dose Phase - Day 26 - Clinical Chemistry Result

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

24HR Local Laboratory Result Data
Description

24HR Local Laboratory Result Data

Date sample taken
Description

Date sample taken

Data type

date

Time sample taken
Description

Time sample taken

Data type

time

Has the subject fasted?
Description

Has the subject fasted?

Data type

boolean

Clinical Chemistry Test
Description

Clinical Chemistry Test

TSH
Description

TSH

Data type

float

Measurement units
  • U/ml
U/ml
T4
Description

T4

Data type

float

Measurement units
  • g/dL
g/dL
Triglycerides
Description

Triglycerides

Data type

float

HDL
Description

HDL

Data type

float

Measurement units
  • mg/dL
mg/dL
Calculated LDL
Description

Calculated LDL

Data type

float

Measurement units
  • mmol/L
mmol/L
Total Cholesterol
Description

Total Cholesterol

Data type

float

If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
Description

If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.

Data type

text

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Similar models

Part 2: Repeat Dose Phase - Day 26 - Clinical Chemistry Result

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
24HR Local Laboratory Result Data
Date sample taken
Item
Date sample taken
date
Time sample taken
Item
Time sample taken
time
Has the subject fasted?
Item
Has the subject fasted?
boolean
Item Group
Clinical Chemistry Test
TSH
Item
TSH
float
T4
Item
T4
float
Triglycerides
Item
Triglycerides
float
HDL
Item
HDL
float
Calculated LDL
Item
Calculated LDL
float
Total Cholesterol
Item
Total Cholesterol
float
If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
Item
If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
text
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