Study Of Lybrel In Relation To Venous Thromboembolism
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Venous Thrombosis Pulmonary Embolism Sinus Thrombosis, Intracranial |
Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism |
- deep vein thrombosis (DVT) [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- pulmonary embolism (PE) [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- cerebral venous sinus thrombosis (CVST) [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 598682 |
| Study Start Date: | July 2007 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01297348 History of Changes |
| Obsolete Identifiers: | NCT01316640 |
| Other Study ID Numbers: | 0858A2-4406, B3121004 |
| Study First Received: | February 14, 2011 |
| Last Updated: | July 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Lybrel levonorgestrel ethinyl estradiol venus thromboembolism (VTE) |
oral contraceptives (OC) safety database study case-control study |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Sinus Thrombosis, Intracranial Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism 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 Contraceptive Agents Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Levonorgestrel Ethynylestradiol mixture with norethindrone Norinyl Ethinyl estradiol, levonorgestrel drug combination Contraceptives, Oral Estradiol Polyestradiol phosphate Ethinyl Estradiol |
ClinicalTrials.gov processed this record on May 16, 2013