2,781
Views
24
CrossRef citations to date
0
Altmetric
Research Article

Impact of a new levonorgestrel intrauterine system, Levosert®, on heavy menstrual bleeding: results of a one-year randomised controlled trial

, , , , , , , , , , & show all

Figures & data

Figure 1 Levosert® and its inserter are depicted in picture (A) and in insert a, respectively. Mirena® and its inserter are shown in picture (B) and in insert b, respectively.

Figure 1 Levosert® and its inserter are depicted in picture (A) and in insert a, respectively. Mirena® and its inserter are shown in picture (B) and in insert b, respectively.

Figure 2 Randomised controlled trial profile.

Figure 2 Randomised controlled trial profile.

Table 1 Baseline characteristics of the intention-to-treat population.

Table 2 Changes from baseline in menstrual blood loss (mL), ferritin (μg/L), haemoglobin (g/dL) and endometrial thickness (mm) after one year of treatment with Levosert® and Mirena® presented as least-squares mean (see Statistical analysis).

Figure 3 Decrease in menstrual blood loss (mL) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 3 Decrease in menstrual blood loss (mL) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 4 Increase in ferritin level (μg/L) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 4 Increase in ferritin level (μg/L) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 5 Increase in haemoglobin level (g/dL) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 5 Increase in haemoglobin level (g/dL) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 6 Decrease in endometrial thickness (mm) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Figure 6 Decrease in endometrial thickness (mm) over the first treatment year with Levosert® and Mirena®. ITT, intention-to-treat; SEM, standard error of the mean.

Table 3 Drug-related adverse events occurring in at least 5% of the women of each treatment group.