Oral Contraceptive Interaction Study for GW273225
GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in a large number of patients. This study will investigate whether there is any effect of GW273225 upon the components of combined oral contraceptive, and also whether taking oral contraceptives affects the pharmacokinetics (PK) of GW273225.
26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Repeat Dose Study to Investigate the Effect of Co-administration of the Combined Oral Contraceptive Pill (COC) and GW273225 on the Pharmacokinetics of the COC and to Investigate the Effects of the COC on the Pharmacokinetics of GW273225 in Healthy Female Subjects|
- 0-24hrs PK of oral contraceptive components [ Time Frame: 0-24hrs ]
- 0-24hrs PK of GW273225 Hormone levels with co-administration of oral contraceptive and GW273225 [ Time Frame: 0-24hrs ]
- blood drug levels of GW273225 in the presence or absence of the Combined Oral Contraceptive (COC)
- blood levels of ethinylestradiol and levonorgestrel of the COC in the presence or absence of GW273225.
- blood levels of FSH, LH and progesterone
- blood levels of Oestradiol and SBHG
- Electrocardiogram (ECG) recordings
- Adverse events
- Vital signs
|Study Start Date:||March 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483535
|GSK Investigational Site|
|Cambridge, Cambridgeshire, United Kingdom, CB3 7TR|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|