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Study Of Lybrel In Relation To Venous Thromboembolism

Sponsored by Pfizer

About this trial

Last updated 12 years ago

Study ID

0858A2-4406

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
15 to 49 Years
Female
Female

Not accepting

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?

Yes

Inclusion Criteria

- New users of the study drugs (i.e., Lybrel and the comparison OCs)

No

Exclusion Criteria

- No specific exclusion criteria for the base study cohort.