Four-Year Efficacy and Safety of the Liletta® Levonorgestrel Intrauterine System [11A] : Obstetrics & Gynecology

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Four-Year Efficacy and Safety of the Liletta® Levonorgestrel Intrauterine System [11A]

Thomas, Michael MD; Chen, Beatrice A. MD, MPH; Keder, Lisa M. MD, MPH; Kimble, Thomas D. MD; Jensen, Jeffrey T. MD, MPH; Creinin, Mitchell D. MD

Author Information

University of Cincinnati, Cincinnati, OH

Financial Disclosure: Michael Thomas disclosed the following—Medicines 360: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received. Lisa Keder disclosed the following—Bayer: Consultant/Advisory Board; Duramed: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Medicine 360: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Teva: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received. Thomas Kimble disclosed the following—Agile: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Allergan: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; Bayer: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Chemo: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Medicines360: Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Merck: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Mithra: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received. Jeffrey Jensen disclosed the following—Abbvie: Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Agile: Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Bayer: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; ContraMed: Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; FHI360: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support; HRA pharma: Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Medicines360: Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; Merck: Consultant/Advisory Board, Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received; MicroChips: Consultant/Advisory Board; Teva: Consultant/Advisory Board. The other authors did not report any potential conflicts of interest.

Obstetrics & Gynecology 129(5):p 11S-12S, May 2017. | DOI: 10.1097/01.AOG.0000514246.36176.80

Abstract

INTRODUCTION: 

Liletta is a levonorgestrel 52 mg contraceptive intrauterine system (IUS) currently approved for contraception for up to three years based on an ongoing multicenter trial evaluating the product for up to seven years of use. We evaluated four-year efficacy and safety data for Liletta.

METHODS: 

Women aged 16-45 years were enrolled and followed in the clinical trial. Women aged 36-45 years received the IUS for safety evaluation only. We assessed four-year pregnancy rates (by Pearl Index and life-table analysis) and safety outcomes.

RESULTS: 

Successful IUS placement occurred in 1,568 (98%) women aged 16-35 years and 146 (97%) women aged 36-45 years, including 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among women 16-35 years at enrollment, eight pregnancies occurred including one following perforation and one following expulsion. Six (75%) pregnancies were ectopic. The eight pregnancies included three nulliparous women and one obese woman. The Pearl Index in the first year was .15 (95% CI .02-.55). Cumulative life-table pregnancy rates through years two, three and four were .49 (95% CI .22-1.09), .60 (95% CI .28-1.26) and .78 (95% CI .37, 1.60). Perforation following IUS placement occurred in two (0.1%) women; both were diagnosed within the first year. Expulsion was reported in 63 (3.7%) participants, most (50 [80.6%]) during the first year of use. Pelvic infection was diagnosed in 12 (.7%) women. Only 38 (2.2%) women discontinued due to bleeding complaints.

CONCLUSION: 

Liletta is highly effective and safe over four years of use in nulliparous and parous women as well as non-obese and obese women.

© 2017 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.

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