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.