Subject and clinician experience with the levonorgestrel-releasing intrauterine system
Received 24 August 2007; received in revised form 3 September 2007; accepted 7 September 2007. published online 23 November 2007.
Refers to erratum:
Erratum to “Subject and clinician experience with the levonorgestrel-releasing intrauterine system” [Contraception 77(2008) 22–29]
, 14 April 2008
Jeffrey T. Jensen, Anita L. Nelson, Antonio C. Costales
Contraception
June 2008 (Vol. 77, Issue 6, Page 466) Full Text |
Full-Text PDF (56 KB)
Abstract
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.
ABSTRACT