A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: GSK189075 (Drug); Brevicon (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: An Open Label, Single-sequence, Repeat-dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Oral contraceptive pill (OC) drug levelsblood hormone levels
Secondary outcome: Adverse eventsECGs, Clinical laboratory tests vital signs
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Locations and Contacts
GSK Investigational Site, Miramar, Florida 33025, United States
Additional Information
Starting date: April 2007
Last updated: May 31, 2012
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