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Continuous or Extended Cycle Oral Contraceptives & Venous Thromboembolism (VTE)

Basic Details
Status
Complete
Last Updated
Monday, March 5, 2018
Health Outcome(s)
venous thromboembolism (VTE)
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

FDA decided that no action is necessary at this time, based on available information.

Analytic Code Link(s) (1)
Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Result(s) (2)
Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (2)
Presentation: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Publication: Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database