Skip to main content
Erschienen in: Archives of Gynecology and Obstetrics 1/2012

01.01.2012 | General Gynecology

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

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

Erschienen in: Archives of Gynecology and Obstetrics | Ausgabe 1/2012

Einloggen, um Zugang zu erhalten

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.
Literatur
1.
Zurück zum Zitat Speroff L, Fritz M (2004) Clinical gynecologic endocrinology and infertility, 7th edn. Lippincott Williams & Wilkins, Baltimore, pp 575–593 Speroff L, Fritz M (2004) Clinical gynecologic endocrinology and infertility, 7th edn. Lippincott Williams & Wilkins, Baltimore, pp 575–593
2.
Zurück zum Zitat 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 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
3.
Zurück zum Zitat 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 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
4.
Zurück zum Zitat 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 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
5.
Zurück zum Zitat 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 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
6.
Zurück zum Zitat 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 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
7.
Zurück zum Zitat 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 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
8.
Zurück zum Zitat 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 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
9.
Zurück zum Zitat Inki P (2007) Long-term use of the levonorgestrel-releasing intrauterine system. Contraception 75(Suppl 6):S161–S166PubMedCrossRef Inki P (2007) Long-term use of the levonorgestrel-releasing intrauterine system. Contraception 75(Suppl 6):S161–S166PubMedCrossRef
10.
Zurück zum Zitat Mansour D (2007) Modern management of abnormal uterine bleeding—the levonorgestrel intra-uterine system. Best Pract Res Clin Obstet Gynaecol 21:1007–1021PubMedCrossRef Mansour D (2007) Modern management of abnormal uterine bleeding—the levonorgestrel intra-uterine system. Best Pract Res Clin Obstet Gynaecol 21:1007–1021PubMedCrossRef
11.
Zurück zum Zitat Tang GWK, Lo SST (1995) Levonorgestrel intrauterine device in the treatment of menorrhagia in chinese women: efficacy versus acceptability. Contraception 51(4):231–235PubMedCrossRef 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Luukkainen T, Toivonen J (1995) Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 52:269–276PubMedCrossRef Luukkainen T, Toivonen J (1995) Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 52:269–276PubMedCrossRef
15.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Higham J, O’Brien PMS, Shaw RW (1990) Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 97:734–739PubMedCrossRef 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.
Zurück zum Zitat Hallberg L, Nilsson L (1964) Determination of menstrual blood loss. Scand J Clin Lab Invest 16:244–248PubMedCrossRef Hallberg L, Nilsson L (1964) Determination of menstrual blood loss. Scand J Clin Lab Invest 16:244–248PubMedCrossRef
21.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat Barrington JW, Bowen-Simpkins P (1997) The levonorgestrel intrauterine system in the management of menorrhagia. Br J Obstet Gynaecol 104(5):614–616PubMedCrossRef Barrington JW, Bowen-Simpkins P (1997) The levonorgestrel intrauterine system in the management of menorrhagia. Br J Obstet Gynaecol 104(5):614–616PubMedCrossRef
25.
Zurück zum Zitat Hurskainen R, Paavonen J (2004) Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol 16:487–489PubMedCrossRef Hurskainen R, Paavonen J (2004) Levonorgestrel-releasing intrauterine system in the treatment of heavy menstrual bleeding. Curr Opin Obstet Gynecol 16:487–489PubMedCrossRef
26.
Zurück zum Zitat 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 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.
Zurück zum Zitat National Collaborating Center for Women’s, Children’s Health (2007) Heavy menstrual bleeding. Clinical guideline. RCOG Press, London, pp 116–120 National Collaborating Center for Women’s, Children’s Health (2007) Heavy menstrual bleeding. Clinical guideline. RCOG Press, London, pp 116–120
28.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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
Metadaten
Titel
The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia
verfasst von
Jan Endrikat
George Vilos
Christoph Muysers
Michel Fortier
Erich Solomayer
Eeva Lukkari-Lax
Publikationsdatum
01.01.2012
Verlag
Springer-Verlag
Erschienen in
Archives of Gynecology and Obstetrics / Ausgabe 1/2012
Print ISSN: 0932-0067
Elektronische ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-011-1902-1

Weitere Artikel der Ausgabe 1/2012

Archives of Gynecology and Obstetrics 1/2012 Zur Ausgabe

Update Gynäkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert – ganz bequem per eMail.