BACKGROUND: Because use of intrauterine contraception is now expanding, this article reports early US clinical experience with the levonorgestrel-releasing intrauterine system (LNG IUS) and assesses subjects' and clinicians' judgment of the adequacy of product information and the overall level of product satisfaction in order to provide insight to new providers of the LNG IUS. STUDY DESIGN: Multicenter, open-label, uncontrolled, Phase IIIb study. Investigators had no prior experience with the LNG IUS. Subjects and investigators completed surveys and questionnaires at 3, 6 and 12 months. RESULTS: A total of 509 women, aged 18 to 45 years, were enrolled in this study between July 2000 and June 2002, and 506 (99.4%) received a LNG IUS after the first (488/506, 95.9%) or second (18/20, 90%) insertion attempt. Insertion was rated as "easy" by 91.8% of investigators. Continuation rate at 12 months was 79%. Primary reasons for premature discontinuation were expulsion (4.5%) and menstrual cycle problems (3.8%). Most subjects (84.5%) indicated a high level of satisfaction with the LNG IUS. CONCLUSION: Over 95% of women had successful insertions of the LNG IUS at first attempt, and less than 1% were unsuccessful after two attempts. Both clinicians and subjects were highly satisfied with product information and their experience with the LNG IUS. One-year continuation rates were comparable to those of other reversible methods.
BACKGROUND: Because use of intrauterine contraception is now expanding, this article reports early US clinical experience with the levonorgestrel-releasing intrauterine system (LNG IUS) and assesses subjects' and clinicians' judgment of the adequacy of product information and the overall level of product satisfaction in order to provide insight to new providers of the LNG IUS. STUDY DESIGN: Multicenter, open-label, uncontrolled, Phase IIIb study. Investigators had no prior experience with the LNG IUS. Subjects and investigators completed surveys and questionnaires at 3, 6 and 12 months. RESULTS: A total of 509 women, aged 18 to 45 years, were enrolled in this study between July 2000 and June 2002, and 506 (99.4%) received a LNG IUS after the first (488/506, 95.9%) or second (18/20, 90%) insertion attempt. Insertion was rated as "easy" by 91.8% of investigators. Continuation rate at 12 months was 79%. Primary reasons for premature discontinuation were expulsion (4.5%) and menstrual cycle problems (3.8%). Most subjects (84.5%) indicated a high level of satisfaction with the LNG IUS. CONCLUSION: Over 95% of women had successful insertions of the LNG IUS at first attempt, and less than 1% were unsuccessful after two attempts. Both clinicians and subjects were highly satisfied with product information and their experience with the LNG IUS. One-year continuation rates were comparable to those of other reversible methods.