CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 598,682 enrolled
Drug / intervention
90ug levonorgestrel / 20 ug ethinyl estradiol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01297348
NCT01297348N/ACompleted

Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism

Pfizer·observational·Posted Feb 16, 2011·Updated Jul 17, 2013

In Brief

An observational study evaluating 90ug levonorgestrel / 20 ug ethinyl estradiol and Oral Contraceptives containing 20 ug of ethinyl estradiol for Venous Thrombosis and 2 related conditions. Completed, enrolled 598,682 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 16, 2011
Enrollment StartJul 1, 2007
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.4 years ago

Interventions

90ug levonorgestrel / 20 ug ethinyl estradioldrug

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

Oral Contraceptives containing 20 ug of ethinyl estradioldrug

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