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Technology Evaluation

LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years

Pages 1131-1140 | Received 03 Mar 2017, Accepted 07 Jul 2017, Published online: 02 Aug 2017
 

ABSTRACT

Introduction: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20.

Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported.

Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.

Article highlights

  • Intrauterine devices and implants are first line contraceptive options for adolescents and nulliparous women because of their safety, efficacy and convenience.

  • Four levonorgestrel intrauterine systems are currently available. Two are approved for three years and two are approved for five years of use.

  • The newest LNG-IUS 12 (Kyleena) shares a smaller frame size and a narrower introducer with the lowest dose LNG-IUS 8 (Skyla/Jaydess) to facilitate easier and potentially less painful placement compared to the larger IUSs.

  • The new LNG-IUS 12 is approved for up to five years of use, just as the higher dose LNG-IUS 20 (Mirena), but has much lower rates of amenorrhea, a bleeding pattern that may not be well tolerated, especially by younger women.

  • These features of this new IUS may better meet the needs of women who might not otherwise consider using IUDs and it may encourage more clinicians to offer IUDs more frequently to their patients.

  • All three of the Bayer LNG-IUSs use the same placement process using introducers that vary only in the diameter of the placement tubing, which simplifies training requirements and clinical practice.

This box summarizes key points contained in the article

Declaration of interest

AL Nelson reports grants/research from Agile, Bayer, ContraMed, Merck; Honoraria/Speakers Bureau from Allergan, Aspen, Bayer, Merck, Teva; Consultant/Advisory Board participation from Allergan, Afile, Bayer, ContraMed, Female Health Co., Merck, MicroCHIPS Biotech, Pharmanest. The author has no other affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Additional information

Funding

This paper was not funded.

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