Obstetrics & Gynecology

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Obstetrics & Gynecology:
doi: 10.1097/AOG.0000000000000019
Contents: Original Research

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

Nelson, Anita MD; Apter, Dan MD, PhD; Hauck, Brian MD; Schmelter, Thomas PhD; Rybowski, Sarah MBBS; Rosen, Kimberly MD; Gemzell-Danielsson, Kristina MD, PhD

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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

© 2013 by The American College of Obstetricians and Gynecologists.

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