ID

33810

Description

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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Versions (1)
  1. 12/28/18 12/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 28, 2018

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License

Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

English

Study Completion

1 forms  
  1. StudyEvent: ODM
    1. Study Completion
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Visit Number
Description

Visit Number

Data type

text

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

text

Visit Date
Description

Visit Date

Data type

date

Study Termination
Description

Study Termination

Date of Final Contact
Description

Date of Final Contact

Data type

date

Date of Last Dose
Description

Date of Last Dose

Data type

date

Did subject complete the study?
Description

Did subject complete the study?

Data type

boolean

Date of discontinuation
Description

Date of discontinuation

Data type

date

If subject discontinued the study, mark one reason
Description

reason for study discontinuation

Data type

text

If Other, please specify details
Description

If Other, specify

Data type

text

AE Number in case of liver chemistry stopping criteria
Description

AE Number in case of liver chemistry stopping criteria

Data type

integer

AE Number in case of adverse event
Description

AE Number in case of adverse event

Data type

integer

AE Number in case of severe or repeated occurrences of hypoglycemia
Description

AE Number in case of severe or repeated occurrences of hypoglycemia

Data type

integer

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Study Completion

1 forms
  1. StudyEvent: ODM
    1. Study Completion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Completion (1)
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
300 (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Visit Date
Item
Visit Date
date
Item Group
Study Termination
Date of Final Contact
Item
Date of Final Contact
date
Date of Last Dose
Item
Date of Last Dose
date
Did subject complete the study?
Item
Did subject complete the study?
boolean
Date of discontinuation
Item
Date of discontinuation
date
Item
If subject discontinued the study, mark one reason
text
reason for study discontinuation
Code List
If subject discontinued the study, mark one reason
CL Item
Liver chemistry stopping criteria (record AE Number below in a corresponding line) (1)
CL Item
Adverse Event (record AE number below in a corresponding line) (2)
CL Item
Severe or repeated occurrences of hypoglycemia (record AE number below in a corresponding line) (3)
CL Item
Consent withdrawal (4)
CL Item
Lost to Follow-Up (5)
CL Item
Protocol violation (6)
CL Item
Noncompliance with study visit schedule (7)
CL Item
Termination of study by sponsor (8)
CL Item
Pregnancy (9)
CL Item
Other (10)
If Other, specify
Item
If Other, please specify details
text
AE Number in case of liver chemistry stopping criteria
Item
AE Number in case of liver chemistry stopping criteria
integer
AE Number in case of adverse event
Item
AE Number in case of adverse event
integer
AE Number in case of severe or repeated occurrences of hypoglycemia
Item
AE Number in case of severe or repeated occurrences of hypoglycemia
integer
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