Levonorgestrel

(Mirena®)

Mirena®

Drug updated on 11/4/2024

Dosage FormInsertion (intrauterine: 52 mg)
Drug ClassProgestin
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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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • The levonorgestrel-releasing intrauterine system (LNG-IUS) demonstrated a substantial reduction in menstrual blood loss (MBL), with reductions up to 90% in some studies and a mean reduction of 105.71 mL per cycle (95% CI (confidence interval): -201.10 to -10.33). LNG-IUS was also more effective than various other medical therapies (e.g., norethisterone acetate, tranexamic acid) in reducing MBL by a margin of 66.91 mL (95% CI: 42.61 to 91.20).
  • When compared to endometrial ablation or resection, LNG-IUS showed no significant differences in satisfaction rates, quality of life improvements, or rates of subsequent hysterectomy. However, LNG-IUS offered superior reduction in MBL over antifibrinolytics and long-cycle progestogens, remaining a leading choice for first-line treatment in heavy menstrual bleeding.
  • The LNG-IUS has a similar rate of serious adverse events compared to other medical therapies for heavy menstrual bleeding. However, users of LNG-IUS are more likely to experience any adverse event than those treated with endometrial ablation/resection (RR (relative risk) 2.06, 95% CI 1.44 to 2.94).
  • Common adverse effects of LNG-IUS leading to discontinuation include bleeding irregularities, pain, and systemic progestogenic side effects, with up to 60% of women discontinuing LNG-IUS within five years due to these issues. One study found that LNG-IUS users had a notably higher rate of treatment failure requiring hysterectomy for heavy menstrual bleeding at one year compared to those who underwent hysterectomy (RR 48.18, 95% CI 2.96 to 783.22).
  • Among reproductive-aged women with heavy menstrual bleeding, LNG-IUS showed favorable outcomes, with effectiveness notably differentiated by age: younger women (≤ 42 years) had a higher likelihood of needing subsequent hysterectomy after endometrial ablation/resection compared to those using LNG-IUS (RR 5.26, 95% CI 1.21 to 22.91), whereas older women (> 42 years) exhibited a non-significant trend towards fewer subsequent hysterectomies with endometrial ablation/resection than with LNG-IUS (RR 0.51, 95% CI 0.21 to 1.24).

Product Monograph / Prescribing Information

Document TitleYearSource
Mirena (levonorgestrel) Prescribing Information.2024Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis2022The Cochrane Database Of Systematic Reviews
LNG-IUS vs. medical treatments for women with heavy menstrual bleeding: A systematic review and meta-analysis2022Frontiers In Medicine
Interventions to prevent or treat heavy menstrual bleeding or pain associated with intrauterine-device use2022The Cochrane Database Of Systematic Reviews
Discontinuation rates of intrauterine contraception due to unfavourable bleeding: a systematic review2022Bmc Women'S Health
Progestogen-releasing intrauterine systems for heavy menstrual bleeding2020The Cochrane Database Of Systematic Reviews
Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis2020Human Reproduction Update
Levonorgestrel-Releasing Intrauterine System as a Contraceptive Method in Nulliparous Women: A Systematic Review2020Journal Of Clinical Medicine
What is the best drug treatment for premenopausal women with bleeding irregularities using the levonorgestrel-releasing intrauterine system? A systematic review2020The European Journal Of Contraception & Reproductive Health Care : The Official
Effectiveness and safety of extending intrauterine device duration: a systematic review2020American Journal Of Obstetrics And Gynecology
Menstrual bleeding and spotting with the Levonorgestrel Intrauterine System (52 mg) during the first-year after insertion: a systematic review and meta-analysis2020American Journal Of Obstetrics And 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