Objective. To compare the bleeding patterns associated with the
3-year use of copper intrauterine devices (Cu-IUD) or 13.5-mg
levonorgestrel-releasing intrauterine systems (LNG-IUS) in clinical
practice. Design. Single-centre, double-blind, randomized, parallel
group, Phase IV study. Setting. Gynaecology office. Population or
Sample. Women seeking long-term contraception, eligible to use
Cu-IUD/LNG-IUS. Methods. At baseline and at months 3, 6, 12, 24 and 36
after placement, we recorded the number of bleeding days and quantity of
bleeding: self-reported bleeding intensity, the Pictorial Blood
Assessment Chart (PBAC) and haemoglobin/ferritin levels and haematocrit.
The frequency and intensity of dysmenorrhoea and spotting, and of
adverse events were also recorded. Main Outcome Measures. Bleeding days
and quantity of bleeding in 90-day reference periods (RPs). Results.
One-hundred six women aged 32.5±6.7 years participated in the study: 55
women were randomized to LNG-IUS and 51 to Cu-IUD. The median number of
bleeding days and the bleeding intensity (self-perceived and PBAC score)
were significantly lower with LNG-IUS throughout the study (P
<0.001), with a greater reduction during RP2 (month 2 for
PBAC). Ferritin levels increased with LNG-IUS and decreased with Cu-IUD.
The frequency and intensity of dysmenorrhoea decreased significantly
more with LNG-IUS vs Cu-IUD. The median number of spotting days was 0 or
close to 0 throughout the study with both devices. Conclusions The
13.5-mg LNG-IUS shows benefits over the Cu-IUD in terms of menstrual
bleeding pattern, being associated with significant blood loss reduction
and greater reduction of the frequency and intensity of dysmenorrhoea,
with similar patterns of spotting days.
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