An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers
- Conditions
- CF10013326mucoviscidosis10040789
- Registration Number
- NL-OMON40637
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 47
Healthy premenopausal female subjects age 18 to 50 years of age. Stable regimen of monophasic OC containing EE (30 µg)/LVG (150 µg) for at least three cycles prior to dosing in treatment period.;Any Subject not taking any OC or taking another brand of;monophasic OC (which does not contain 30 µg EE and 150 µg LVG);should be willing to take a monophasic OC containing 30 µg EE and;150 µg LVG for at least three cycles during synchronization until day -7.;Negative pregnancy test results at screening and both baseline;visits.
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.;Women of child-bearing potential, defined as all women;physiologically capable of becoming pregnant, unless they are using contraception methods.;Women who are either heterozygous or homozygous for the Factor V Leiden mutation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Confirmatory<br /><br>PK<br /><br>PD</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>