Objective: The aim of the study was to provide an additional, detailed description of early bleeding patterns with the 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS). Methods: We conducted a pooled analysis of the bleeding diaries of participants in a previously reported phase II randomised controlled study (n ¼ 741) and a phase III study (n ¼ 2904), with 2year extension phase (n ¼ 707), of the 19.5 mg LNG-IUS. Main outcome measures were the median number of bleeding and/or spotting days per 30-day reference period for 12 months and the influence of the previous contraceptive method and levonorgestrel dose on bleeding patterns. Results: The pooled analysis comprised 1697 women. There was a progressive decline in the number of bleeding and/or spotting days from month 1: the proportion of women with 4 bleeding and/or spotting days per month increased from 6.2% in month 1 to 15.8% in month 2, 26.0% in month 3, 39.3% in month 6 and 54.1% in month 12. The median number of bleeding and/or spotting days in month 1 was lowest in women who had previously been using an LNG-IUS. Conclusion: Analysis of bleeding diaries using 30-day reference periods provides detailed insight into bleeding changes in the first months following placement of the 19.5 mg LNG-IUS. This insight may prove useful when counselling women about contraceptive choice and method continuation.

Purpose: The Kyleena V R Satisfaction Study (KYSS) is a prospective, observational study conducted to assess satisfaction with LNG-IUS 12 (Kyleena V R) in clinical practice and aims to provide adequate information for counselling women on what to expect regarding insertion and satisfaction. Materials and methods: Women deciding to use LNG-IUS 12 during routine counselling were informed of the study and provided informed consent. A baseline analysis was conducted to evaluate demographics, ease of insertion assessed by investigators, pain at insertion rated by women, additional interventions for insertion, and adverse events. Results: 1,110 women (536 parous, 574 nulliparous) had an insertion attempt and were included. Insertion was rated as easy in 494 (92.2%) parous and 516 (89.9%) nulliparous women. Pain was assessed as none or mild by 475 (88.6%) parous and 387 (67.4%) nulliparous women. Additional interventions were not required for most insertions (705; 63.6%). Overall 111 (10.0%) women reported adverse events at the time of baseline analysis. Conclusions: This analysis demonstrates that LNG-IUS 12 insertion is easy and associated with no or mild pain in most women. Additional interventions for insertion are not required in most cases. After 3 months, the number of adverse events is low. Implications: The present baseline analysis of the Kyleena V R Satisfaction Study (KYSS) demonstrates that most women rate insertion pain of LNG-IUS 12 as none or mild and clinicians consider insertion easy in the majority of cases.

No abstract