N/A
Completed N=598,682
Study Of Lybrel In Relation To Venous Thromboembolism
venous thrombosis · Chronic Obstructive Pulmonary Disease · Sinus Thrombosis, Intracranial
Source: ClinicalTrials.gov NCT01297348 ↗
Enrolled (actual)
598,682
Serious AEs
—
Results posted
May 2013
Primary outcomePrimary: Incidence Rate of Idiopathic Venous Thromboembolism (VTE) — 176.2; 87.5; 50.5; 54.1 incidence rate per 100000 person-years
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Idiopathic Venous Thromboembolism (VTE) |
176.2; 87.5; 50.5; 54.1; 18.0; 17.6 | — |
| PRIMARY Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls |
17; 276; 53; 47; 1144; 254 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01297348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.