About this trial
Last updated 12 years ago
Study ID
0858A2-4406
Status
Completed
Type
Observational
Placebo
No
Accepting
15 to 49 Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 13 years ago
What is this trial about?
Lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl
estradiol (90 μg/20 μg). Lybrel is taken on a continuous basis without a placebo or
pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of
the 2 hormones for as long as the drug is used. Lybrel was marketed in the US in July of
2007. The objective of this database case-control study is to estimate the risk of
idiopathic VTE (deep vein thrombosis and pulmonary embolism) in current users of Lybrel
(ethinyl estradiol 20ug/levonorgestrel 90ug) compared to current users of other oral
contraceptives containing 20μg of ethinyl estradiol.
What are the participation requirements?
Inclusion Criteria
- New users of the study drugs (i.e., Lybrel and the comparison OCs)
Exclusion Criteria
- No specific exclusion criteria for the base study cohort.