ID
33716
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
Keywords
Versions (1)
- 12/20/18 12/20/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 20, 2018
DOI
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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
Visit 50
- StudyEvent: ODM
Description
Informed Consent
Description
Admission Criteria
Description
Failed Eligibility Criteria
Description
If the subject did not meet all eligibility criteria, please specify criteria number and explain below
Data type
integer
Description
Check One Criteria Type
Data type
integer
Description
Waiver Granted?
Data type
boolean
Description
Date of Sponsor Approval
Data type
date
Description
Comment
Data type
text
Description
Demographics
Description
Race
Description
Check all that apply
Data type
integer
Description
If Other, please specify
Data type
text
Description
Potentially Childbearing
Description
Electrocardiogram
Description
Date ECG performed
Data type
date
Description
Time ECG performed
Data type
time
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
PR Interval
Data type
integer
Measurement units
- msec
Description
QRS Duration
Data type
float
Measurement units
- msec
Description
QT Interval
Data type
float
Measurement units
- msec
Description
QTcB Interval
Data type
float
Measurement units
- msec
Description
QTcF Interval
Data type
float
Measurement units
- msec
Description
RR Interval
Data type
float
Measurement units
- msec
Description
Normal sinus rhythm?
Data type
boolean
Description
Overall interpretation of ECG
Description
Hematology Test
Description
Chemistry / Serum HCG / SP Chemistry
Description
Was the laboratory sample collected?
Data type
boolean
Description
Sample Date
Data type
date
Description
Sample Time
Data type
time
Description
Comment
Data type
text
Description
Pregnancy test result
Data type
text
Description
UA / UDS / Urine Chemistry
Description
Serology
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Visit 50
- StudyEvent: ODM