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| ID | Type | Description | Link |
|---|---|---|---|
| B3121004 |
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| Name | Class |
|---|---|
| Boston Collaborative Drug Surveillance Program | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90ug levonorgestrel / 20 ug ethinyl estradiol | Drug | This is a non-interventional observational database study, thus no interventions are offered to patients in the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Idiopathic Venous Thromboembolism (VTE) | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lybrel | Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed. |
| FG001 | Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) | Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lybrel | Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed. |
| BG001 | Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of Idiopathic Venous Thromboembolism (VTE) | 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. | Analysis population included all enrolled participants who met the eligibility criteria. | Posted | Number | incidence rate per 100000 person-years | Index date (date of VTE diagnosis for case and corresponding date for matched control) |
|
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The minimum criteria for reporting an adverse event (AE) (that is, identifiable participant, identifiable reporter, a suspect product, and event) were not available and adverse events were not reportable as individual AE reports in this observational non-interventional study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lybrel | Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed. |
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Data for DVT, PE and CVST were not reported separately as the 3 were components of the primary endpoint VTE and not separate endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D012851 | Sinus Thrombosis, Intracranial |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| C526369 | lybrel |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C484525 | ovcon 35 |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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|
| Oral Contraceptives containing 20 ug of ethinyl estradiol | Drug | This is a non-interventional observational database study, thus no interventions are offered to patients in the study. |
|
|
Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Percentage of Participants With Duration in Health Plan Before First Study OC Prescription | Duration in health plan was categorized into 4 categories: 6 to 12, 12 to 24, 24 to 60 and more than 60 months. Health plan was referred to the managed care plans which included information on paid claims for pharmaceuticals, medical diagnoses, procedures and demographic information on the participants. | Number | percentage of participants |
|
| Percentage of Obese Participants | Number | percentage of participants |
|
| Percentage of Participants With Gynecological Disorders | Percentage of participants were reported for following gynecological disorders: endometriosis, menstrual disorder and uterine leiomyoma. | Number | percentage of participants |
|
| Percentage of Participants With Back Pain | Number | percentage of participants |
|
| Percentage of Participants With Cardiovascular Disease | Number | percentage of participants |
|
| Percentage of Participants With Hypertension | Number | percentage of participants |
|
| Percentage of Participants With Hyperlipidemia | Number | percentage of participants |
|
| Percentage of Participants With Diabetes | Number | percentage of participants |
|
| Percentage of Participants With Asthma | Number | percentage of participants |
|
| Percentage of Participants With Thyroid Disease | Number | percentage of participants |
|
| Percentage of Participants With Length of Stay in Health Plan | Length of stay in health plan was categorized into: less than 1, 1 to 2, 3 to 4 and greater than or equal to 5 years. Health plan was referred to the managed care plans which included information on paid claims for pharmaceuticals, medical diagnoses, procedures and demographic information on the participants. | Number | percentage of participants |
|
Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
| OG001 | Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) | Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed. |
| OG002 | Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20) | A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed. |
|
|
|
| Primary | Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls | 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. | Analysis population included all enrolled participants who met the eligibility criteria. | Posted | Number | participants | Index date (date of VTE diagnosis for case and corresponding date for matched control) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) | Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D020767 | Intracranial Thrombosis |
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013923 | Thromboembolism |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
|
| Past user: Case |
|
| Past user: Matched Control |
|
Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).
| Odds Ratio (OR) |
| 2.53 |
| 2-Sided |
| 95 |
| 0.98 |
| 6.54 |
| No |
| Superiority or Other |