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

Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial.

Author information

  • 1Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, California; the Sexual Health Clinic (Family Federation of Finland), Väestöliitto, Helsinki, Finland; the Department of Obstetrics and Gynecology, Foothills Hospital, University of Calgary, Calgary, Alberta, Canada; Bayer Pharma AG, MülleBerlin, Germany; Bayer HealthCare Pharmaceuticals, Montville, New Jersey; and the Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.

Erratum in

  • Obstet Gynecol. 2014 May;123(5):1109.

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.

Comment in

PMID:
24240244
[PubMed - indexed for MEDLINE]
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