Levonorgestrel-releasing intrauterine system

(Mirena®)

Mirena®

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Drug updated on 4/17/2024

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.

Summary
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  • The Levonorgestrel-releasing intrauterine system (Mirena) is indicated for the prevention of pregnancy for up to 8 years and the treatment of heavy menstrual bleeding in women who choose this method for contraception, effective up to 5 years.
  • A total of 12 systematic reviews and meta-analyses provided extensive insight into the safety, effectiveness, and comparison of Mirena with other methods in various clinical indications such as preventing pregnancy and treating heavy menstrual bleeding.
  • The evidence suggests a slightly increased risk of breast cancer among users, especially postmenopausal women or those with prolonged use. However, these findings are contested due to variability in results across studies requiring further research.
  • Some studies indicate a potential association between the usage of Mirena and psychiatric symptoms including depressive symptoms, anxiety, and suicidality, emphasizing the need for thorough psychiatric assessment before insertion.
  • For Heavy Menstrual Bleeding (HMB), Mirena has been hailed as an excellent first-line treatment due to its significant reduction in blood loss compared to other therapies like nonsteroidal anti-inflammatory drugs or oral progestogens. It also shows high satisfaction rates when compared against surgical treatments like endometrial ablation/resection or hysterectomy, despite surgical options potentially leading to more definitive outcomes under certain conditions.
  • Among nulliparous women specifically, Mirena showed high levels of satisfaction, effective contraception, and an acceptable bleeding pattern suggesting it can be used safely even by a population previously considered at higher risk for complications from intrauterine devices.
  • One study documented that there was a general decrease in both spotting days over the first year of use, setting realistic expectations for new users about the impact on menstrual patterns.
  • The combination of LNG-IUS insertion immediately following endometrial ablation/resection appears to reduce re-intervention rates, suggesting a synergistic effect could offer an improved strategy for HMB.

Product Monograph / Prescribing Information

Document TitleYearSource
Mirena (levonorgestrel) 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