NCT01953809 - A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women | Biotech Hunter

Timeline

Start Date

August 31, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions

Infections, Bacterial

Interventions

DRUG

GSK1322322

Oral tablets with unit dose strength of 500mg and dose level of 1500mg (3 x 500mg) for twice a day administration for 7 days in treatment phase

DRUG

EE/NE

Oral contraceptive tablet containing 0.035mg EE and 1mg NE for once daily administration for 21 days in run-in phase and 21 days in treatment phase

DRUG

GSK1322322 Placebo

GSK1322322 matching placebo tablets for twice a day administration (3 tablets each time) for 7 days in treatment period.

DRUG

EE/NE Placebo

EE/NE matching placebo tablet for once daily administration for 7 days in run-in phase.