Overview

Study Of Lybrel In Relation To Venous Thromboembolism

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
Boston Collaborative Drug Surveillance Program
Treatments:
Contraceptive Agents
Contraceptives, Oral
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Polyestradiol phosphate
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.