One-sequence, two-period, open-label study to evaluate the effects of FTY720 on the pharmacokinetics of an oral contraceptive (levonorgestrel/ethinyl estradiol) in healthy female volunteers.
Completed
- Conditions
- MSmultiple sclerose10012303
- Registration Number
- NL-OMON35177
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
Female, 18-40 years of age, BMI 18-29 kg/m2, OC-user, healthy
Exclusion Criteria
Clinical significant abnormalities during screening and baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main purpose of this investigation is to examine how the new drug FTY720<br /><br>(study medication) will be absorbed, metabolized and excreted by the body in<br /><br>combination with the contraception pill which consists of ethinyl-estradiol and<br /><br>levonorgestrel.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The other purposes of this investigation are:<br /><br>• To examine how the contraception pill, which consists of ethinyl-estradiol<br /><br>and levonorgestrel, will be absorbed, metabolized and excreted by the body in<br /><br>combination with the new drug FTY720 (study medication).<br /><br>• To examine the safety and tolerability of the new drug FTY720 (study<br /><br>medication) in combination with the contraception pill which consists of<br /><br>ethinyl-estradiol and levonorgestrel.</p><br>