Drug updated on 12/11/2024
Dosage Form | Insertion (intrauterine: 52 mg) |
Drug Class | Progestin |
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.
Latest News
Summary
- 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% confidence interval (CI): -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 (relative risk (RR) 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 Title | Year | Source |
---|---|---|
Mirena (levonorgestrel) Prescribing Information. | 2024 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guideline no. 437: Diagnosis and management of adenomyosis | 2023 | Journal of Obstetrics and Gynecology Canada |
Consensus of best practice in intrauterine contraception in France. | 2019 | The European Journal of Contraception & Reproductive Health Care |