Levonorgestrel 52 mg IUS effective and safe >6 years

  • Westhoff CL & al.
  • Contraception
  • 28.11.2019

  • von Elisabeth Aron, MD, MPH, FACOG
  • Clinical Essentials
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Takeaway

  • Levonorgestrel 52 mg intrauterine system (IUS) is safe and effective for at least 6 years.

Why this matters

  • These data may affect FDA approval guidelines to allow for use past 5 years.

Key results

  • No pregnancies in year 6 by Pearl Index (0.00; 95% CI, 0.00-0.94).
  • 40.4% experienced amenorrhea in the 90 days preceding the end of year 6.
  • 72.2% 16-35-year-olds and 83.6% 36-45-year-olds discontinued study participation.
  • Reasons for discontinuation: adverse event (19.2%), seeking pregnancy (15.5%), loss to follow-up or withdrawal of consent (15.1%), or relocation away from the study site (6.5%).
  • Reason for discontinuation due to adverse event: partial or complete expulsion (4.0%), bleeding complaint (2.3%).
  • Adverse events included: acne, weight increase, mood swings, pelvic pain.

Study design

  • Phase 3 of an ongoing prospective observational study, ACCESS IUS, to evaluate 16-35-year-olds (n=1600) for up to 10 years and 36-45-year-olds (n=151) for up to 8 years after levonorgestrel 52 mg IUS placement.
  • Primary outcome: any pregnancy with a conception date from the insertion date through 7 days of IUS discontinuation.
  • Secondary outcomes: cumulative Pearl Indices over 6 years and life-table pregnancy rates.
  • Funding: Medicines360.

Limitations

  • Study in year 6 of 10.