Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.

Abstract

Objective: To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use.

Study design: Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study.

Results: A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints.

Conclusion: The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women.

Implications statement: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

Trial registration: ClinicalTrials.gov NCT00995150.

Keywords: Contraception; Intrauterine device; Levonorgestrel; Liletta.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Contraception / methods*
  • Contraceptive Agents, Female / administration & dosage*
  • Female
  • Humans
  • Intrauterine Device Expulsion
  • Intrauterine Devices, Medicated / adverse effects*
  • Levonorgestrel / administration & dosage*
  • Middle Aged
  • Parity
  • Pelvic Infection / epidemiology
  • Pelvic Infection / etiology
  • Pregnancy
  • Pregnancy Rate
  • Time Factors
  • Uterine Hemorrhage / epidemiology
  • Uterine Hemorrhage / etiology
  • Young Adult

Substances

  • Contraceptive Agents, Female
  • Levonorgestrel

Associated data

  • ClinicalTrials.gov/NCT00995150