Bleeding Pattern and Safety of Consecutive Use of the Levonorgestrel-Releasing Intrauterine System (LNG-IUS)—A Multicentre Prospective Study

Abstract

Contraception with intrauterine delivery of levonorgestrel (LNG) using the LNG-releasing intrauterine system (LNG-IUS) is highly effective. LNG-IUS is also used to provide endometrial protection during menopausal estrogen replacement therapy and for management of idiopathic menorrhagia. An increasing number of women choose to replace this device after the first 5 years of use with another LNG-IUS, and thereby, use the device consecutively. There are few published data on the effect of consecutive use of the LNG-IUS on bleeding patterns. The aim of this prospective 15-month multicenter study was to investigate bleeding patterns in the last 90 days of the first LNG-IUS use and during the first year of use of the second LNG-IUS among fertile-aged women. The removal and insertion procedures were also characterized. In addition, the safety of LNG-IUS and reasons for discontinuation were assessed. The study was conducted at 17 clinics in 4 European countries. The participants were fertile-aged women who had been using their first LNG-IUS for between 4 years 3 months and 4 years 9 months, and who chose to replace the first device immediately after its removal, with a second LNG-IUS. The primary study efficacy variable was the bleeding pattern during the last 3 months of the first LNG-IUS, and the first year of use of the second LNG-IUS. Bleeding patterns were compared in five 90-day reference periods (the last 90-days of use of the first device, and first year of the second use). A patient diary was used to assess bleeding. A total of 204 (87%) of the 234 subjects who were screened entered the trial. During the last 90 days of the first LNG-IUS, the median number of bleeding per spotting days reported was 7. This increased to 8 days during the first 90-day reference period of the second LNG-IUS, as result of bleeding associated with insertion; subsequently, the median number of bleeding per spotting days decreased to 4 days during the next 3 reference periods. In the majority of the cases, removal and insertion of the LNG-IUS were easy. The procedures were generally well tolerated. There was only 1 expulsion. No discontinuations due to pregnancy, perforation, or pelvic inflammatory disease were noted. Among the 12 patients (5.9%) who prematurely discontinued the study, reasons for early withdrawal in 5 were adverse effects; there were other reasons for the other 7, including 2 consent withdrawals, and 2 lost to follow-up. These findings suggest that consecutive use of the LNG-IUS should be encouraged due to its favorable bleeding pattern and excellent safety profile.