From the Guidelines
Liletta (levonorgestrel) is not approved for 7 years of use, but rather for 5 years, as indicated by the FDA approval 1. The FDA has approved Liletta for 5 years of use, with a failure rate of 0.1% in the first year of typical use 1. While there may be evidence for extended use of some intrauterine devices, Liletta's approved duration is currently 5 years, containing 52 mg of levonorgestrel, which is slowly released into the uterus, providing reliable contraception by thickening cervical mucus, inhibiting sperm movement, thinning the uterine lining, and sometimes preventing ovulation. Some key points to consider when using Liletta include:
- Failure rate: 0.1% in the first year of typical use
- Approved duration: 5 years
- Active ingredient: 52 mg of levonorgestrel
- Common side effects: irregular bleeding patterns, cramping, and potential ovarian cysts. Regular check-ups are recommended to ensure proper placement and address any concerns, and patients should be aware that while Liletta can be used for the full 5 years, it can also be removed earlier if pregnancy is desired or if side effects become problematic.
From the Research
Liletta 7 Year Use
- Liletta (levonorgestrel) is suitable for 7 years of use, as evidenced by studies that evaluated its efficacy and safety for up to 8 years 2, 3.
- The 52-mg levonorgestrel-releasing intrauterine system, which is the same as Liletta, has been shown to maintain high contraceptive efficacy and a favorable safety profile through 8 years of use 2.
- A study that evaluated the efficacy and safety of the levonorgestrel 52 mg intrauterine system during years 7 and 8 of use found that the system is highly effective over 8 years of use and has an excellent extended safety profile 3.
Efficacy and Safety
- The Pearl Index, which measures contraceptive efficacy, was 0.28 (95% confidence interval) for years 6 to 8, indicating high efficacy 2.
- The cumulative failure rate was 0.68% (95% confidence interval) for years 6 to 8, indicating a low risk of pregnancy 2.
- Amenorrhea rates were 39% at both years 7 and 8, indicating that many women experience a decrease in menstrual bleeding over time 3.
Bleeding Patterns
- A study that evaluated bleeding patterns for the Liletta levonorgestrel 52 mg intrauterine system found that amenorrhea and infrequent bleeding become more prevalent over time, and amenorrhea rates continue to increase after the first year of use 4.
- The study also found that discontinuation for bleeding-related complaints is uncommon, occurring in only 2.1% of women during the first 36 months 4.
Overall
- The evidence suggests that Liletta is a highly effective and safe contraceptive option for up to 7 years of use, with a low risk of pregnancy and a favorable safety profile 2, 3.
- Women who use Liletta can expect a decrease in menstrual bleeding over time, with many experiencing amenorrhea or infrequent bleeding 3, 4.