Bleeding patterns with the 19.5 mg LNG-IUS, with special focus on the first year of use: implications for counselling

Abstract

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.

Predicting menstrual bleeding patterns with levonorgestrel-releasing intrauterine systems

“…devices, and the lower-dose LNG-IUS 8 with a higher number of bleeding and spotting days than is LNG-IUS 12, differences that may limit the comparability of the devices [13,17,32]. Furthermore, it is possible that confounding variables such as hormone levels, stress, external influences and intermenstrual bleeding, which are inherently difficult to identify correctly, may preclude modelling of cycle regularity.…”

“…In terms of informing women initiating LNG-IUS about potential changes in bleeding patterns, anticipatory counselling is very important [40]. Bleeding pattern during the first 3 months post-placement is considered a major determinant of method tolerability and continuation, with increased bleeding frequency and heavier volume of bleeding being associated with decreased satisfaction [7,17,20]. Information in the product label and from clinical trials can guide HCPs when counselling women, but no model is currently available to predict future bleeding outcomes on an individual basis.…”

“…Both classification models assumed that a woman would enter bleeding-diary data without missing entries and would attend a check-up 90 days after LNG-IUS placement where she could receive further counselling; 90 days is recognised as the interval post-placement during which bleeding patterns are most affected by LNG-IUSs [17]. Available information at this point included baseline variables and 90 days of a daily bleeding diary ( Figure 1).…”

“…Changes in bleeding pattern with an LNG-IUS are likely to be dose-dependent. In a 12-month analysis, LNG-IUS 20 (MirenaV R ; average LNG release rate of 20 lg/24 h over first year) and LNG-IUS 12 (Kyleena V R ; average LNG release rate of 12 lg/24 h over first year) were associated with higher proportions of women with no bleeding or spotting days than was LNG-IUS 8 (Jaydess V R /Skyla V R ; average LNG release rate of 8 lg/24 h over first year) [17].…”

“…Association of particular bleeding patterns with different contraceptive methods can influence women's choice of, and persistence with a method. For example, an expectation of amenorrhoea was shown to influence method satisfaction with LNG-IUS [21], and less bleeding or amenorrhoea appear to be important reasons why women choose LNG-IUS [17]. Fears of menstrual irregularity can deter some women from using hormonal contraception [22], so it is important to counsel about the likelihood of unpredictable, frequent or heavy bleeding [4].…”