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    Kyleena®

    (19.5mg intrauterine delivery system Levonorgestrel)

    Kyleena Model Image

    A low dose, effective contraception without a daily routine

    Kyleena is a low daily hormone dose (12 μg per day over the first year, and averaging 9 μg per day over 5 years) which can be appealing to women. Independent of user compliance, age and parity, Kyleena provides highly effective contraception with a 5-year Pearl Index of 0.29.*

    Kyleena® therapeutic indications:

    • Contraception for up to 5 years.

    • More than 99% efficacy for each year of use.

    • A cumulative failure rate of approximately 1.4% over 5 years.

    * 1-year Pearl Index: 0.16 (95% Cls 0.02-0.58). 5-year Pearl Index: 0.29 (95% Cls 0.16-0.50). The failure rate was approximately 0.2% at 1 year.

    Kyleena Physical properties

    Kyleena®: Smaller T-Body and narrower insertion tube than a Mirena

    With a 3.8 mm insertion tube:

    • Placement of Kyleena is considered easy in 90% of women, regardless of parity.
    • 96% success rate at first insertion attempt.
    • Women rated the pain of placement as 'none' or 'mild' in 65% of cases.

    Fast facts on Kyleena

    In this video, Dr Jane Davis, highlights key facts that are beneficial for healthcare professionals to know when counselling patients about Kyleena.

    Duration
    | 6 minutes 31 seconds

    Prescribing information for Kyleena® can be found here:

    Kyleena® Prescribing Information

    Kyleena® is associated with high rates of user satisfaction

    Almost 90% of women reported that they were 'very satisfied' or 'somewhat satisfied' with Kyleena®

    90% Icon

    Study details:

    After 3 years, 89% said they were 'very satisfied' or 'somewhat satisfied' with Kyleena.*

    Study design:

    In this Phase III study, 2885 nulliparous and parous women aged 18–35 years were randomized to LNG‐IUS 8 or LNG-IUS 12 for 3 years. After 3 years, women using LNG-IUS 12 could continue for up to 2 additional years (5 years total). The primary outcome was occurrence of pregnancy (Pearl Index). Secondary outcomes included safety, bleeding, dysmenorrhea, discontinuations, and user satisfaction.

    * Study dates: From August 2007 through May 2008.

    Over 80% of women would continue with Kyleena® after study completion if given the choice.

    80% Icon

    Study details:

    After 3 years, 89% said they were 'very satisfied' or 'somewhat satisfied' with Kyleena.*

    Study design:

    In this Phase III study, 2885 nulliparous and parous women aged 18–35 years were randomized to LNG‐IUS 8 or LNG-IUS 12 for 3 years. After 3 years, women using LNG-IUS 12 could continue for up to 2 additional years (5 years total). The primary outcome was occurrence of pregnancy (Pearl Index). Secondary outcomes included safety, bleeding, dysmenorrhea, discontinuations, and user satisfaction.

    * Study dates: From August 2007 through May 2008.

    PP-KYL-IE-0252-1   |   January 2026

      Referencesexpand_less
      • 1
        Kyleena® 19.5 mg intrauterine delivery system (levonorgestrel): Summary of Product Characteristics.
      • 2
        Gemzell-Danielsson K, et al. Eur J Obstet Gynecol Reprod Biol, 2017;210:22–28.
      • 3
        Mansour D. Int J Women’s Health, 2014;6:367–375.
      • 4
        Nelson A, et al. Obstet Gynecol, 2013;122:1205–1213.
      • 5
        Nelson AL, et al. Expert Rev Clin Pharmacol, 2017;10(8):833–342.