A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
NCT ID: NCT00504816
Last Updated: 2012-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2007-04-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brevicon
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
GSK189075
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
GSK189075
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
Brevicon
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Interventions
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GSK189075
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
Brevicon
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* able to take a specific oral contraceptive \& KG2107494.
* female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
* female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.
Exclusion Criteria
* female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
* Have suffered with certain infection within 4 weeks prior to the first dose of study drug
18 Years
45 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Miramar, Florida, United States
Countries
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Other Identifiers
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KG2107494
Identifier Type: -
Identifier Source: org_study_id
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