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A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.

HIV Infections Clinical Trial

Official title:
A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Drospirenone and Ethinyl Estradiol When Co-administered With GSK2248761 in Healthy Adult Female Subjects

Clinical Trial Summary

This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods. The length of the Run-in Period will be 28 days or longer, depending on the timing of the subject's menstrual cycle and on whether the subject is taking an OC. Each subject will participate in this run-in period (if needed), followed by two treatment periods. Treatment Periods 1 and 2 must be conducted successively. Subjects will be randomized in a cross-over fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or placebo for another 10 days. Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.

Clinical Trial Description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01195974
Study type Interventional
Source ViiV Healthcare
Contact
Status Terminated
Phase Phase 1
Start date September 14, 2010
Completion date February 9, 2011
View Details
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