Study Of Lybrel In Relation To Venous Thromboembolism

NCT ID: NCT01297348

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 598682 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-04-30

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.

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.

Conditions

Venous Thrombosis; Pulmonary Embolism; Sinus Thrombosis, Intracranial

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

90ug levonorgestrel / 20 ug ethinyl estradiol

Intervention Type: DRUG

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

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)

Oral Contraceptives containing 20 ug of ethinyl estradiol

Intervention Type: DRUG

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

Interventions

90ug levonorgestrel / 20 ug ethinyl estradiol

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lybrel; 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

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Collaborative Drug Surveillance Program

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0858A2-4406&StudyName=Study%20Of%20Lybrel%20In%20Relation%20To%20Venous%20Thromboembolism

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Other Identifiers

B3121004

Identifier Type: -

Identifier Source: secondary_id

0858A2-4406

Identifier Type: -

Identifier Source: org_study_id

NCT01316640

Identifier Type: -

Identifier Source: nct_alias