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Study Of Lybrel In Relation To Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT01297348
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : May 27, 2013
Last Update Posted : July 17, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Venous Thrombosis Pulmonary Embolism Sinus Thrombosis, Intracranial Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol

Detailed Description:
The base population consists of all currently available data on current users (15-49 years old) of Lybrel and other oral contraceptives (OC) containing 20 µg ethinyl estradiol in the PharMetrics/IMS and MarketScan databases. From among the base population, the databases are then searched for any diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) [referred to collectively as venous thromboembolism or VTE] that occurred after receipt of Lybrel or other oral contraceptives containing 20 µg ethinyl estradiol. The intent is to include newly diagnosed cases of VTE.

Study Design

Study Type : Observational
Actual Enrollment : 598682 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
Study Start Date : July 2007
Primary Completion Date : April 2012
Study Completion Date : April 2012


Groups and Cohorts

Group/Cohort Intervention/treatment
Lybrel®
Current users of 90 ug levonorgestrel / 20 ug ethinyl estradiol - cases and controls (i.e., women diagnosed with new venus thromboembolism [VTE] and women not diagnosed with VTE).
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.
Other Name: Lybrel
Other OCs containing 20μg of ethinyl estradiol
Current users of oral contraceptives containing 20μg of ethinyl estradiol - cases and controls (i.e. women diagnosed with new VTE and women not diagnosed with VTE)
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.
Other Name: Lessina, Aviane, Junel 1/20, Junel FE 1/20, Levlite, Lutera, Alesse, Loestrin FE 1/20, Loestrin 1/20, Microgestin 1/20, Microgestin FE 1/20


Outcome Measures

Primary Outcome Measures :
  1. Incidence Rate of Idiopathic Venous Thromboembolism (VTE) [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ]
    Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.

  2. Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ]
    Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The base population for each year of the study will comprise all 15 - 49 year old women who have any recorded prescriptions for either continuous use ethinyl estradiol 20ug/levonorgestrel 90ug or a cyclic oral contraceptive that contains 20 µg ethinyl estradiol. The women are identified from PharMetrics and MarketScan databases. Additionally, women are enrolled if the index prescription is a new one; this is defined as a prescription dispensed following a 4-month window in which no combined hormonal contraception prescriptions were filled.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297348


Sponsors and Collaborators
Pfizer
Boston Collaborative Drug Surveillance Program
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01297348     History of Changes
Obsolete Identifiers: NCT01316640
Other Study ID Numbers: 0858A2-4406
B3121004
First Posted: February 16, 2011    Key Record Dates
Results First Posted: May 27, 2013
Last Update Posted: July 17, 2013
Last Verified: June 2013

Keywords provided by Pfizer:
Lybrel
levonorgestrel
ethinyl estradiol
venus thromboembolism (VTE)
oral contraceptives (OC)
safety
database study
case-control study

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Sinus Thrombosis, Intracranial
Intracranial Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estrogens
Hormones