Levonorgestrel-Releasing Intrauterine System May Reduce Menstrual Blood Loss

Laurie Barclay, MD

August 26, 2010

August 26, 2010 — For women with documented idiopathic heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system is associated with a greater reduction in menstrual blood loss and a higher likelihood of treatment success than treatment with oral medroxyprogesterone acetate, according to the results of a multicenter study reported in the September issue of Obstetrics & Gynecology.

"It is well known that LNG-IUSs [levonorgestrel-releasing intrauterine systems] reduce significantly menstrual blood loss," Dirk Wildemeersch, MD, PhD, medical director of Contrel Research in Ghent, Belgium, told Medscape Medical News when asked for independent comment. "The main strength [of this study] is that the superiority of the LNG-IUS, when compared with oral progestins, is demonstrated in a randomized, controlled trial."

The goal of this study, by Andrew M. Kaunitz, MD, from the University of Florida College of Medicine in Jacksonville, and colleagues, was to compare the efficacy and safety of the levonorgestrel-releasing intrauterine system for the treatment of idiopathic heavy menstrual bleeding vs oral medroxyprogesterone acetate. Participants were women at least 18 years old with heavy menstrual bleeding, defined as menstrual blood loss of at least 80 mL per cycle.

Of 807 women screened, 165 were randomly assigned to 6 cycles of treatment with either the levonorgestrel-releasing intrauterine system (n = 82) or oral medroxyprogesterone acetate (10 mg daily for 10 days beginning on day 16 of each cycle; n = 83). The main efficacy outcomes were absolute change in menstrual blood loss from baseline to study end, and the proportion of women with treatment success, defined as menstrual blood loss less than 80 mL per cycle and at least a 50% reduction in menstrual blood loss from baseline.

Compared with the medroxyprogesterone acetate group, the levonorgestrel-releasing intrauterine system group had a significantly greater reduction in median menstrual blood loss at study end (-128.8 mL; range, -393.6 to +1242.2 mL vs -17.8 mL; range -271.5 to +78.6 mL; P < .001). Furthermore, 84.8% of women in the levonorgestrel-releasing intrauterine system group had treatment success vs 22.2% of women in the medroxyprogesterone acetate group (P < .001).

"The study demonstrates the superiority of the LNG IUS in treating heavy menstrual bleeding," Anita L. Nelson, a principal investigator on this trial and a professor of obstetrics and gynecology at David Geffen School of Medicine at UCLA, Torrance, California, told Medscape Medical News. "Combined with other research, we can see that the LNG IUS can easily replace surgery for most women with this problem (unless they have other pelvic pathology) and should be tried before resorting to ablation or hysterectomy."

Most of the reported adverse events were of mild to moderate intensity in both groups.

When asked about limitations of this study, Dr. Wildemeersch pointed out that other trials of levonorgestrel-releasing intrauterine systems have shown that ferritin levels increase significantly but that this outcome was not evaluated in this study.

The study authors note that higher efficacy with oral medroxyprogesterone acetate observed in previous studies may be attributed, in part, to the higher progestin dose and longer treatment duration per cycle vs this study. However, this study used the highest oral medroxyprogesterone acetate dose (10 mg) and the longest duration of treatment (10 days) approved for abnormal uterine bleeding in the United States.

"In women with idiopathic menorrhagia, the LNG-IUS should be used prior to considering surgery as up to 100% of women will be treated effectively," Dr. Wildemeersch concluded. "Additional research could be done to evaluate the effect of the LNG-IUS or other compound released in the uterus on heavy menstrual bleeding, including in women with uterine pathologies such as adenomyosis, fibroids, and bleeding disorders."

Bayer Schering Pharma AG funded this study, employs 2 of its authors, and has disclosed various financial relationships with other study authors. Dr. Wildemeersch has been involved in the invention and clinical development of various hormone-releasing intrauterine systems for more than 15 years. Dr. Nelson sits on advisory boards for the levonorgestrel-releasing intrauterine system.

Obstet Gynecol. 2010;116:625-632. Abstract

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