Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: A Randomized Controlled Trial

Obstet Gynecol. 2013 Dec;122(6):1205-13. doi: 10.1097/AOG.0000000000000019.

Abstract

Objective: To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems.

Methods: Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems: 13.5 mg total content or 19.5 mg total content. The primary outcome was the pregnancy rate, calculated as the Pearl Index.

Results: Overall, 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups, respectively, had a placement attempted and were included in the full analysis set to evaluate efficacy and safety. Mean (standard deviation) age was 27.1 (4.8) years; 39.2% were nulliparous. Over the 3-year study period, 0.33 pregnancies per 100 women-years (95% confidence interval [CI] 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI 0.15-0.57) with the 19.5 mg intrauterine contraceptive system. Kaplan-Meier estimates for that period were 0.009 and 0.010, respectively. At least partial expulsions occurred in 4.56% and 3.58% and discontinuation rates resulting from a reported adverse event occurred in 21.9% and 19.1%, respectively. Ten of the 20 pregnancies were ectopic. Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation.

Conclusions: Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00528112.

Level of evidence: : I.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Female
  • Humans
  • Intrauterine Device Expulsion
  • Intrauterine Devices, Medicated / adverse effects*
  • Levonorgestrel / administration & dosage*
  • Levonorgestrel / adverse effects
  • Pelvic Inflammatory Disease / etiology
  • Pregnancy
  • Pregnancy Rate*
  • Pregnancy, Unplanned
  • Uterine Perforation / etiology
  • Young Adult

Substances

  • Levonorgestrel

Associated data

  • ClinicalTrials.gov/NCT00528112