A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

In brief

The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.

Key facts

Study ID

NCT00504816

Run by

GlaxoSmithKline

People needed

22

Starts

2007-04-01

Expected to finish

2008-04-01

Last updated by the study team

2012-06-04

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
• 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.

You may not qualify if…

• pregnant or a nursing female.
• 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

Where it is running

• GSK Investigational Site — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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