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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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) [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 49 and Day 75 ]
- blood levels of ethinylestradiol and levonorgestrel of the COC in the presence or absence of GW273225. [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 21 and Day 49 ]
- blood levels of FSH, LH and progesterone [ Time Frame: Up to Day 45 ]
- blood levels of Oestradiol and SBHG [ Time Frame: Up to Day 45 ]
- Electrocardiogram (ECG) recordings [ Time Frame: Up to Day 96 ]
- Adverse events [ Time Frame: Up to Day 96 ]
- Vital signs [ Time Frame: Up to Day 96 ]
|Actual Study Start Date:||March 7, 2007|
|Study Completion Date:||November 16, 2007|
|Primary Completion Date:||November 16, 2007 (Final data collection date for primary outcome measure)|
Experimental: Sequence ABC
All subjects will receive the treatment sequence ABC where A=combined oral contraceptive pill (COC), B=COC plus GW273225 and C=GW273225. COC will be administered in two cycles that is, cycle 1 (Days 1-21) and cycle 2 (Days 29-49) of the study. The cycles will be separated by a 7 day washout period. GW273225 will be administered at a dose of one 25 milligram tablet once daily on Days 29-75 of the study.
GW273225 will be available as 25 milligram tablets.Drug: COC
COC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets.
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|