A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
|ClinicalTrials.gov Identifier: NCT00504816|
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : June 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2||Drug: GSK189075 Drug: Brevicon||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||April 2008|
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.
Other Name: GSK189075
- Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ]
- 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. ]
- Adverse events [ Time Frame: all visits after study drug ]
- ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ]
- vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504816
|United States, Florida|
|GSK Investigational Site|
|Miramar, Florida, United States, 33025|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|