Top

Archives of Gynecology and Obstetrics

Published in:

01-01-2012 | General Gynecology

The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia

Authors: Jan Endrikat, George Vilos, Christoph Muysers, Michel Fortier, Erich Solomayer, Eeva Lukkari-Lax

Published in: Archives of Gynecology and Obstetrics | Issue 1/2012

Abstract

Objectives

Idiopathic menorrhagia (IM) is an important clinical challenge. The levonorgestrel-releasing intrauterine system (LNG IUS) provides an effective treatment option as shown by multiple small clinical studies. In this analysis of combined data, we describe the time course of relative change in menstrual blood loss (MBL) from baseline up to 5 years. The results of two different methods to assess MBL were merged.

Methods

We pooled and analyzed five prospective, randomized clinical studies investigating the effect of the LNG IUS on IM in a total of 230 women. Four studies assessed MBL by using the pictorial blood loss assessment chart (PBAC) and one study used the alkaline hematin method. We gathered data on percentage change from baseline after 3 and 6 months, and annually up to 5 years. In addition we analyzed results on hemoglobin (Hb) and serum ferritin (S-Fe).

Results

MBL data was available after 3 and 6 months from 165 and 152 patients, respectively, and after 1 year from 51 patients. Long-term data up to 3 and 5 years was available for 28 and 10 patients, respectively. Not all studies provided data for all time points. Median (interquartile range) MBL decreased from baseline by −84.5% (−93.3; −63.6%) after 3 months, by −92.9% (−97.6; −81.1%) and by −93.8% (−98.8; −81.1%) after 6 months and 1 year, respectively (P < 0.0001, all time points). After 2 and 5 years the decrease was more than 96%. In parallel, Hb and S-Fe increased significantly.

Conclusion

The LNG IUS rapidly induced clinically and statistically significant long-term reductions in MBL, paralleled by increases in Hb and S-Fe levels.

Speroff L, Fritz M (2004) Clinical gynecologic endocrinology and infertility, 7th edn. Lippincott Williams & Wilkins, Baltimore, pp 575–593

Reid P, Virtanen-Kari S (2005) Randomised comparative trial of the levonorgestrel intrauterine system and mefenamic acid for the treatment of idiopathic menorrhagia: a multiple analysis using total menstrual fluid loss, menstrual blood loss and pictorial blood loss assessment charts. BJOG 112(8):1121–1125PubMedCrossRef

Milsom I, Andersson K, Andersch B, Rybo G (1991) A comparison of flurbiprofen, tranexamic acid, and a levonorgestrel-releasing intrauterine contraceptive device in the treatment of idiopathic menorrhagia. Am J Obstet Gynecol 164:879–883PubMed

Kari S (2005) Randomized, open-label, multicenter study comparing the efficacy and safety of Mirena to a 3-month administration of danazol followed by a 3-month observation period in women aged over 30 with functional menorrhagia: Berlex Canada; Report No.: A00696/DE00650-303003. Data on file

Endrikat J, Shapiro H, Lukkari-Lax E, Kunz M, Schmidt W, Fortier M (2009) A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia. JOGC 31:340–347PubMed

Lahteenmaki P, Haukamaa M, Puolakka J, Riikonen U, Sainio S, Suvisaari J et al (1998) Open randomized study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy. BMJ 316:1122–1126PubMedCrossRef

Nagrani R, Bowen-Simpkins P, Barrington JW (2002) Can the levonorgestrel intrauterine system replace surgical treatment for the management of menorrhagia? BJOG 109:345–347PubMedCrossRef

Hurskainen R, Teperi J, Rissanen P, Aalto AM, Grenman S, Kivela A et al (2004) Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA 291:1456–1463PubMedCrossRef

Inki P (2007) Long-term use of the levonorgestrel-releasing intrauterine system. Contraception 75(Suppl 6):S161–S166PubMedCrossRef

10.

Mansour D (2007) Modern management of abnormal uterine bleeding—the levonorgestrel intra-uterine system. Best Pract Res Clin Obstet Gynaecol 21:1007–1021PubMedCrossRef

11.

Tang GWK, Lo SST (1995) Levonorgestrel intrauterine device in the treatment of menorrhagia in chinese women: efficacy versus acceptability. Contraception 51(4):231–235PubMedCrossRef

12.

Irvine GA, Campbell-Brown MB, Lumsden MA, Heikkila A, Walker JJ, Cameron IT (1998) Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. Br J Obstet Gynaecol 105:592–598PubMedCrossRef

13.

Scholten PC, Christiaens GCML, Haspels AA (1989) Treatment of menorrhagia by intrauterine administration of levonorgestrel. The levonorgestrel IUD: clinical performance and impact on menstruation. University of Utrecht, Utrecht, pp 47–55

14.

Luukkainen T, Toivonen J (1995) Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 52:269–276PubMedCrossRef

15.

Rauramo I, Elo I, Istre O (2004) Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection. Obstet Gynecol 104(6):1314–1321PubMedCrossRef

16.

Crosignani PG, Vercellini P, Mosconi P, Oldani S, Cortesi I, De Giorgi O (1997) Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Obstet Gynecol 90:257–263PubMedCrossRef

17.

Kaunitz AM, Meredith S, Inki P, Kubba A, Sanchez-Ramos S (2009) Levonorgestrel-realising intrauterine system and endometrial ablation in heavy menstrual bleeding. Obstet Gynecol 113:1104–1116PubMed

18.

Muenzen R (2009) A multicenter, randomized, open label, parallel group, active control study to evaluate the efficacy and safety of LNG IUS (Mirena) as compared to medroxyprogesterone acetate during 6 cycles of treatment in patients with idiopathic menorrhagia. BSP Report A38313, 23 Jan. Data on file

19.

Higham J, O’Brien PMS, Shaw RW (1990) Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 97:734–739PubMedCrossRef

20.

Hallberg L, Nilsson L (1964) Determination of menstrual blood loss. Scand J Clin Lab Invest 16:244–248PubMedCrossRef

21.

Janssen CA, Scholten PC, Heintz AP (1995) A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol 85(6):977–982PubMedCrossRef

22.

Xiao B, Wu SC, Chong J, Zeng T, Han LH, Luukkainen T (2003) Therapeutic effects of the levonorgestrel-releasing intrauterine system in the treatment of idiopathic menorrhagia. Fertil Steril 79(4):963–969PubMedCrossRef

23.

Kriplani A, Singh BM, Lal S, Agarwal N (2007) Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia. Int J Gynaecol Obstet 97:190–194PubMedCrossRef

24.

Barrington JW, Bowen-Simpkins P (1997) The levonorgestrel intrauterine system in the management of menorrhagia. Br J Obstet Gynaecol 104(5):614–616PubMedCrossRef

25.

Hurskainen R, Paavonen J (2004) Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol 16:487–489PubMedCrossRef

26.

Hurskainen R, Teperi J, Rissanen P, Aalto AM et al (2004) Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up. JAMA 291:1503–1504CrossRef

27.

National Collaborating Center for Women’s, Children’s Health (2007) Heavy menstrual bleeding. Clinical guideline. RCOG Press, London, pp 116–120

28.

Chrisman C, Ribeiro P, Dalton VK (2007) The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses. Clin Obst Gynecol 50:886–897CrossRef

29.

Andersson K, Batar I, Rybo G (1992) Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T. Contraception 46:575–584PubMedCrossRef

30.

Belhadj H, Sivin I, Diaz S et al (1986) Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T 380 Ag intrauterine device. Contraception 34:261–267PubMedCrossRef

Title: The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia
Authors: Jan Endrikat
George Vilos
Christoph Muysers
Michel Fortier
Erich Solomayer
Eeva Lukkari-Lax
Publication date: 01-01-2012
Publisher: Springer-Verlag
Published in: Archives of Gynecology and Obstetrics / Issue 1/2012
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-011-1902-1

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia

Abstract

Objectives

Methods

Results

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Objectives

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2012

Minimal invasive treatment options in pregnant women with ovarian vein syndrome

Teaching and training in laparoscopic surgery: experience of Catholic Laparoscopy Advanced Surgery School in the basic gynecological surgery

Diagnosis and treatment options of vulvar cancer: a review

The efficacy of the levonorgestrel-releasing intrauterine system in perimenopausal women with menorrhagia or dysmenorrhea

Diagnosis and management of an unilateral giant fibroadenoma of the breast in pregnancy

Association between mannose-binding lectin and interleukin-1 receptor antagonist gene polymorphisms and recurrent vulvovaginal candidiasis