A Study To Evaluate The Effect Of GW876008 On The Pharmacokinetics Of Oral Contraceptive Pills
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|ClinicalTrials.gov Identifier: NCT00508911|
Recruitment Status : Terminated
First Posted : July 30, 2007
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Social Phobia||Drug: GW876008 Drug: COC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Repeat-dose, Single-sequence Study to Investigate the Effects of Once-daily Repeat Oral Administration of GW876008 125mg on the Pharmacokinetics of the Combined Oral Contraceptive in Female Volunteers|
|Actual Study Start Date :||June 8, 2007|
|Actual Primary Completion Date :||October 22, 2007|
|Actual Study Completion Date :||October 22, 2007|
Experimental: Healthy female subjects
Each subject will be administered a monophasic combined oral contraceptive (COC) containing ethinylestradiol 30 micrograms and levonorgestrel 150 micrograms for two complete cycles (Day 8 to Day 28) in Session 1. The subjects will be administered COC on Day 8 to Day 28 and GW876008 125 milligrams on Days 1 to 35 in Session 2.
GW876008 tablets will be available as white to off-white coated tablets. Each subject will receive a single oral dose of GW876008, daily for up to 35 days in Session 2. GW876008 will be administered in the morning with a light breakfast.
Other Name: GW876008 Oral Contraceptive
COC containing ethinylestradiol 30 microgram and levonorgestrel 150 microgram will be administered in the morning with a light breakfast.
- Blood level of oral contraceptive pills [ Time Frame: measured over 24hrs on Day 28 of Period 1 and 2 ]
- 1)PK parameters of oral contraceptives [ Time Frame: Day 28 ]
- 2)PK parameters of GW876008 [ Time Frame: Days 28 and 35 (Period2) ]
- 3)Blood level of sex hormones 4) Frequency of breakthrough bleeding 5) adverse event,12-lead ECG and vital signs and laboratory tests [ Time Frame: (throughout study) ]
- Ethinylestradiol and levonorgestrel blood levels to determine pharmacokinetic parameter [ Time Frame: Session 1: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Session 2: Day 28 at pre-dose (-30 mins), 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose. Days 30-35 ]
- Serum concentrations of LH, FSH. [ Time Frame: Pre-dose on Days 8, 12 and 19 ]
- Serum concentration of progesterone and estradiol [ Time Frame: Pre-dose on Days 25 and 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508911
|GSK Investigational Site|
|Harrow, Middlesex, United Kingdom, HA13UJ|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|