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Randomized Controlled Trial
. 2014 Jun;19(3):169-79.
doi: 10.3109/13625187.2014.894184. Epub 2014 Mar 26.

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

Marie Mawet  1 , Fabrice Nollevaux, Dominique Nizet, Fabienne Wijzen, Valérie Gordenne, Niso Tasev, Dimitrije Segedi, Bogdan Marinescu, Andreea Enache, Vadim Parhomenko, Francis Frankenne, Jean-Michel Foidart
Affiliations
Free PMC article
Randomized Controlled Trial

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

Marie Mawet et al. Eur J Contracept Reprod Health Care. 2014 Jun.
Free PMC article

Abstract

Objective: To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert(®) for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena(®).

Methods: A multicentre, randomised, controlled trial, in non-menopausal women diagnosed with functional HMB (defined as menstrual blood loss [MBL] ≥ 80 mL) randomised to either Levosert(®) or Mirena(®) and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram.

Results: A total of 280 women were randomised (141 to Levosert(®) and 139 to Mirena(®)). During the one-year treatment period, both Levosert(®) and Mirena(®) dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert(®) and Mirena(®) regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert(®) was inserted with the same ease as Mirena(®). Both treatments were associated with identical expulsion rates and no perforations occurred in either treatment group.

Conclusion: Levosert(®), a new LNG-IUS designed to release the same daily amount of LNG as Mirena(®), is highly effective in the treatment of HMB. No differences were observed between Levosert(®) and Mirena(®) regarding all evaluated outcomes, including safety profile.

Keywords: Heavy menstrual bleeding; Intrauterine system; Levonorgestrel; Levosert®; Mirena®.

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Figures

Figure 1
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
Figure 2
Randomised controlled trial profile.
Figure 3
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
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
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
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.
See this image and copyright information in PMC

References

    1. Cote I, Jacobs P, Cumming DC. Use of health services associated with increased menstrual loss in the United States. Am J Obstet Gynecol. 2003;188:343–8. - PubMed
    1. Santer M, Warner P, Wyke S. A Scottish postal survey suggested that the prevailing clinical preoccupation with heavy periods does not reflect the epidemiology of reported symptoms and problems. J Clin Epidemiol. 2005;58:1206–10. - PubMed
    1. Coulter A, Bradlow J, Agass M, et al. Outcomes of referrals to gynaecology outpatient clinics for menstrual problems: An audit of general practice records. Br J Obstet Gynaecol. 1991;98:789–96. - PubMed
    1. Bradlow J, Coulter A, Brooks P. Patterns of referral: A study of referrals to outpatient clinics from general practices in the Oxford Region. Oxford: Health Services Research Unit; 1992.
    1. Duckitt K. Managing perimenopausal menorrhagia. Maturitas. 2010;66:251–6. - PubMed

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