A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
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.
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ] [ Designated as safety issue: No ]
- blood hormone levels [ Time Frame: on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone. ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: all visits after study drug ] [ Designated as safety issue: No ]
- ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ] [ Designated as safety issue: No ]
- vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504816
|United States, Florida|
|GSK Investigational Site|
|Miramar, Florida, United States, 33025|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|