Study Of Lybrel In Relation To Venous Thromboembolism

This study has been completed.
Sponsor:
Collaborator:
Boston Collaborative Drug Surveillance Program
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01297348
First received: February 14, 2011
Last updated: June 27, 2013
Last verified: June 2013
Results First Received: April 2, 2013  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Retrospective
Conditions: Venous Thrombosis
Pulmonary Embolism
Sinus Thrombosis, Intracranial
Interventions: Drug: 90ug levonorgestrel / 20 ug ethinyl estradiol
Drug: Oral Contraceptives containing 20 ug of ethinyl estradiol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Lybrel     Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)  
STARTED     12281     586401  
COMPLETED     12281     586401  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Lybrel     Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)     Total  
Number of Participants  
[units: participants]
  12281     586401     598682  
Age, Customized  
[units: participants]
     
15 to 19 years     1549     151591     153140  
20 to 24 years     1785     128757     130542  
25 to 29 years     1925     99632     101557  
30 to 34 years     2079     79184     81263  
35 to 39 years     2074     56674     58748  
40 to 44 years     1668     41299     42967  
45 to 49 years     1201     29264     30465  
Gender  
[units: participants]
     
Female     12281     586401     598682  
Male     0     0     0  
Percentage of Participants With Duration in Health Plan Before First Study OC Prescription [1]
[units: percentage of participants]
     
6 to 12 months     27.6     24.0     51.6  
12 to 24 months     39.1     31.9     71.0  
24 to 60 months     27.5     37.0     64.5  
More than 60 months     5.8     7.1     12.9  
Percentage of Obese Participants  
[units: percentage of participants]
  3.7     3.0     6.7  
Percentage of Participants With Gynecological Disorders [2]
[units: percentage of participants]
     
Endometriosis     6.3     1.1     7.4  
Menstrual disorder     26.8     24.8     51.6  
Uterine leiomyoma     0.1     0.0     0.1  
Percentage of Participants With Back Pain  
[units: percentage of participants]
  11.0     8.5     19.5  
Percentage of Participants With Cardiovascular Disease  
[units: percentage of participants]
  3.3     2.8     6.1  
Percentage of Participants With Hypertension  
[units: percentage of participants]
  6.3     3.7     10.0  
Percentage of Participants With Hyperlipidemia  
[units: percentage of participants]
  8.9     5.5     14.4  
Percentage of Participants With Diabetes  
[units: percentage of participants]
  2.2     1.7     3.9  
Percentage of Participants With Asthma  
[units: percentage of participants]
  6.9     6.8     13.7  
Percentage of Participants With Thyroid Disease  
[units: percentage of participants]
  0.8     0.8     1.6  
Percentage of Participants With Length of Stay in Health Plan [3]
[units: percentage of participants]
     
Less than 1 year     3.7     4.4     8.1  
1 to 2 years     14.6     16.8     31.4  
3 to 4 years     41.8     41.6     83.3  
Greater than or equal to 5 years     40.0     37.2     77.2  
[1] 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.
[2] Percentage of participants were reported for following gynecological disorders: endometriosis, menstrual disorder and uterine leiomyoma.
[3] 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.



  Outcome Measures
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1.  Primary:   Incidence Rate of Idiopathic Venous Thromboembolism (VTE)   [ Time Frame: Index date (date of VTE diagnosis for case and corresponding date for matched control) ]

2.  Primary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data for DVT, PE and CVST were not reported separately as the 3 were components of the primary endpoint VTE and not separate endpoints.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquires@pfizer.com


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
Results First Received: April 2, 2013
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration