Levonorgestrel-releasing intrauterine system

(Mirena®)

Mirena®

Drug updated on 9/4/2024

Dosage FormInsertion (intrauterine: 52 mg)
Drug ClassProgestin-containing intrauterine system
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for prevention of pregnancy for up to 8 years.
  • Indicated for treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years.

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Summary
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  • Mirena (levonorgestrel-releasing intrauterine system) is indicated for prevention of pregnancy for up to 8 years and for treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years.
  • This summary is based on the review of 12 systematic reviews/meta-analyses. [1-12]
  • Six out of ten studies found a positive association between LNG-IUS use and breast cancer, particularly in older women and with longer duration of use. One study specifically indicated an increased risk for invasive breast cancer in women aged 40-45.
  • LNG-IUS use was associated with increased depressive symptoms in 10 studies, while two studies reported reduced symptoms. Additionally, one study found increased anxiety, and another identified a higher risk of suicide.
  • LNG-IUS significantly reduced menstrual blood loss and was more effective than other medical treatments such as tranexamic acid, danazol, and NSAIDs for heavy menstrual bleeding.
  • Hysterectomy and endometrial ablation were more effective than LNG-IUS in reducing menstrual blood loss in second-line treatments for heavy menstrual bleeding.
  • Breast Cancer Risk: LNG-IUS users, particularly older women, may have an increased risk of breast cancer. Hormone-free alternatives may be considered for women with a history of breast cancer.
  • Psychiatric Safety: LNG-IUS is associated with psychiatric symptoms, including depressive symptoms and suicidality. Counseling on these risks is recommended for users.
  • Adverse Effects in Heavy Menstrual Bleeding: LNG-IUS had an acceptable frequency of adverse events, with common effects including weight gain, mood changes, and headaches.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Mirena (levonorgestrel-releasing intrauterine system) Prescribing Information.2022Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Influence of the levonorgestrel-releasing intrauterine system on the risk of breast cancer: A systematic review. 2023Archives of Gynecology and Obstetrics.
The potential association between psychiatric symptoms and the use of levonorgestrel intrauterine devices (LNG-IUDs): A systematic review.2022The World Journal of Biological Psychiatry
Influence of the levonorgestrel-releasing intrauterine system on the risk of breast cancer: A systematic review.2022Archives of Gynecology and Obstetrics
Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis. 2022The Cochrane Database of Systematic Reviews
LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis. 2022Frontiers in Medicine
Association of levonorgestrel intrauterine devices with stress reactivity, mental health, quality of life and sexual functioning: A systematic review.2021Frontiers in Neuroendocrinology
The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: A systematic review.2021Acta Obstetricia et Gynecologica Scandinavica
Levonorgestrel-releasing intrauterine system as a contraceptive method in nulliparous women: A systematic review.2020Journal of Clinical Medicine
Progestogen-releasing intrauterine systems for heavy menstrual bleeding.2020The Cochrane Database of Systematic Reviews
Cyclical progestogens for heavy menstrual bleeding.2020The Cochrane Database of Systematic Reviews
Levonorgestrel-releasing intrauterine system and breast cancer risk: A systematic review and meta-analysis. 2020Acta Obstetricia et Gynecologica Scandinavica
Menstrual bleeding and spotting with the levonorgestrel intrauterine system (52 mg) during the first-year after insertion: A systematic review and meta-analysis.2019American Journal of Obstetrics & Gynecology

Clinical Practice Guidelines

Document TitleYearSource
Guideline no. 437: Diagnosis and management of adenomyosis2023Journal of Obstetrics and Gynecology Canada
Consensus of best practice in intrauterine contraception in France.2019The European Journal of Contraception & Reproductive Health Care