Bleeding profiles associated with two low-dose levonorgestrel intrauterine contraceptive systems over 3 years of use: results of a multicentre, open-label, randomised, Phase III study
ESC Congress Library. Apter D. May 28, 2014; 50571; A-156
Dan Apter
Dan Apter
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Abstract
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Objective


To assess the bleeding profiles associated with two lose-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs); LNG-IUS13.5mg (total content) and LNG-IUS19.5mg (total content).


Method


Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized 1:1 to LNG-IUS13.5mg or LNG-IUS19.5mg, placed within the first 7 days of the cycle. Women with a vaginal delivery, Caesarean section or abortion within 6 weeks before screening were excluded, in part, to assess the impact of lower levonorgestrel doses on vaginal bleeding pattern.


Results


The full analysis set included 1,432 and 1,452 women in the LNG-IUS13.5mg and LNG-IUS19.5mg groups, respectively, for whom at least one attempt at placement was made; 1,355 and 1,376, respectively, had ≥1 evaluable 30-day reference interval and 1,322 and 1,348, respectively, had ≥1 evaluable 90-day reference interval for the bleeding analysis.


The number of bleeding/spotting days decreased over time during use of LNG-IUS13.5mg and LNG-IUS19.5mg; the greatest reduction was between the first and second 30-day reference intervals (RIs); a trend towards fewer bleeding and spotting days was observed in the higher dose group. In both treatment groups, women who switched from hormonal methods (oral contraceptives, implants or LNG-IUS20µg/24hours) had fewer combined bleeding and spotting days in all 30-day RIs during the first 6 months of use compared with women who switched from non-hormonal methods.


The percentage of women with amenorrhoea (WHO criteria) increased over time during use of LNG-IUS13.5mg and LNG-IUS19.5mg. By the penultimate (11th) 90-day RI 10.0% and 19.3% of women in the LNG-IUS13.5mg and LNG-IUS19.5mg groups, respectively, were amenorrhoeic. Among women who developed amenorrhoea, ~60-70% remained amenorrhoeic from one RI to the next, from the fifth 90-day RI onwards.


Endometrial histology was evaluated at the end of 3 years of treatment in a subset of 48 women. Across both treatment groups combined, histology was secretory in 95.8%, proliferative in 2.1% and 'unclassified' in 2.1%.


In both treatment groups, <5% of women discontinued because of bleeding change (including amenorrhoea). Approximately three-quarters of women in both treatment groups reported that they were 'very satisfied' or 'somewhat satisfied' with their bleeding pattern.


Conclusions


Bleeding profiles associated with LNG-IUS13.5mg/LNG-IUS19.5mg were commensurate with that expected of an LNG-IUS. Women switching from oral contraceptives, implants or LNG-IUS20µg/24hours had fewer bleeding and spotting days in the first 6 months of treatment. Bleeding pattern did not correlate with endometrial histology. Discontinuation rates for bleeding problems were low.

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