- 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.
- 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.
- 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.
- Study in year 6 of 10.