- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01297348
Study Of Lybrel In Relation To Venous Thromboembolism
June 27, 2013 updated by: Pfizer
Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism
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 Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
598682
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
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).
|
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
Other Names:
|
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)
|
This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Index date (date of VTE diagnosis for case and corresponding date for matched control)
|
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.
|
Index date (date of VTE diagnosis for case and corresponding date for matched control)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
February 14, 2011
First Submitted That Met QC Criteria
February 14, 2011
First Posted (Estimate)
February 16, 2011
Study Record Updates
Last Update Posted (Estimate)
July 17, 2013
Last Update Submitted That Met QC Criteria
June 27, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Intracranial Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Pulmonary Embolism
- Sinus Thrombosis, Intracranial
- Intracranial Thrombosis
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Oral, Sequential
- Levonorgestrel
- Estradiol
- Contraceptive Agents
- Ethinyl Estradiol
- Contraceptives, Oral
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Norinyl
- Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Other Study ID Numbers
- 0858A2-4406
- B3121004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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