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Study Of Lybrel In Relation To Venous Thromboembolism

NCT01297348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 598682

Last updated 2013-07-17

Study results available
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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.

Conditions

Interventions

DRUG

90ug levonorgestrel / 20 ug ethinyl estradiol

This is a non-interventional observational database study, thus no interventions are offered to patients in the study.

DRUG

Oral Contraceptives containing 20 ug of ethinyl estradiol

This is a non-interventional observational database study, thus no interventions are offered to patients in the study.

Sponsors & Collaborators

  • Boston Collaborative Drug Surveillance Program

    collaborator OTHER

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297348 on ClinicalTrials.gov