Options for treatment of heavy bleeding in focus
Clinicians now have an approved indication in hand for use of the levonorgestrel intrauterine system Mirena (LNG IUS, Mirena, Bayer HealthCare Pharmaceuticals; Wayne, NJ), to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. The Food and Drug Administration (FDA) gave approval to the indication in October 2009, which made Mirena the first intrauterine device approved for this additional use. Mirena was approved as a contraceptive by the FDA in 2000.
Heavy menstrual bleeding can cause impairment in quality of life for women and represents a common reason women consult clinicians; traditionally, surgery has represented the main therapeutic option, says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics And Gynecology Department at the University of Florida College of Medicine — Jacksonville.
With the FDA's approval of use of the LNG IUS for treatment of heavy menstrual bleeding, women with this condition have an effective office-based nonsurgical option, says Kaunitz. Kaunitz presented information from the pivotal trial at the recent Reproductive Health 2009 sponsored by the Association of Reproductive Health Professionals, the Planned Parenthood Federation of America National Medical Committee, and the Society of Family Planning.1
Bleeding is lessened
The pivotal trial was a randomized, open-label, active-control, parallel-group study of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause heavy menstrual bleeding, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss of greater than or equal to 80 ml, was determined using the alkaline hematin method. Scientists followed 79 women who were randomly selected to receive the LNG IUS and compared them to 81 women were randomized to receive oral medroxyprogesterone acetate (MPA) over six menstrual cycles. Researchers defined successful treatment when two outcomes were met:
- a proportion of subjects with end-of-study menstrual blood loss at less than 80 ml;
- a greater than or equal to 50% decrease in menstrual blood loss from baseline to end of study.
The proportion of women who had been successfully treated (defined as menstrual blood loss of less than 80 ml at end of study) was higher in the LNG IUS group (67/79) relative to women in the MPA group (18/81), study findings indicate.1 Of the women treated with MPA, fewer than 30% experienced a more than 50% reduction in menstrual blood loss, compared with more than 80% of women treated with the LNG-IUS, who experienced at least a 70% decrease.1 The study excluded women with organic or systemic conditions that may cause heavy uterine bleeding (except fibroids, with total volume not above 5 ml). The most common reported adverse events for the LNG-IUS in the study were uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness.1
Pill combats bleeding
Science is now eyeing a new hormonal combination oral contraceptive for use in treatment of heavy bleeding. Investigators report that an estradiol valerate/dienogest oral contraceptive (OC) significantly reduces menstrual blood loss in women with heavy and/or prolonged menstrual bleeding without organic pathology.2
The combination pill has been available in several European countries since May 2009 for use as a contraceptive under the trade name Qlaira. Its manufacturer, Bayer, submitted a New Drug Application to the FDA in July 2009. It is seeking approval for two indications: oral contraception and the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.
Qlaira's progestin component, dienogest, has a particularly good effect on the endometrial functions that control bleeding, observes Ian Fraser, MD, professor in reproductive medicine, obstetrics, gynecology, and neonatology at the University of Sydney. The dynamic dosing of Qlaira and its estrogen component, estradiol valerate, are thought to support this action, Fraser notes.
Qlaira's dosing regimen incorporates an estradiol step-down and a progestin step-up designed to provide estrogenic dominance in the first part of the cycle to ensure initial endometrial proliferation and sensitivity for midcycle progestin action.3 The formulation provides progestin dominance during the mid-to-late part of the cycle to ensure endometrial stability, particularly toward the end of the cycle.4
References
- Kaunitz AK, Bissonnette F, Monteiro I, et al. Levonorgestrel intrauterine system and medroxyprogesterone acetate for treatment of heavy menstrual bleeding. Presented at the Reproductive Health 2009 conference. Los Angeles; Sept. 30-Oct. 3, 2009.
- Fraser IS, Zeun S, Machlitt A, et al. A novel oral contraceptive comprising estradiol valerate/dienogest for the treatment of heavy and/or prolonged menstrual bleeding without organic cause: a double-blind, randomized, placebo-controlled trial . Presented at the XIX FIGO World Congress of Gynecology & Obstetrics. Cape Town, South Africa; October 2009.
- Nahum GG, Parke S, Wildt L, et al. Efficacy and tolerability of a new oral contraceptive containing estradiol and dienogest. Presented at the 56th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. New Orleans; May 2008.
- Parke S, Makalova D, Ahrendt HJ, et al. Bleeding patterns and cycle control with a novel four-phasic combined oral contraceptive containing estradiol valerate and dienogest. Eur J Contracept Reprod Health Care 2008; 13(suppl):94.
Resource
The National Association of Nurse Practitioners in Women's Health has a webinar on its web site, www.NPWH.org, on heavy menstrual bleeding. Go to the web page and click on the link under "Abnormal Uterine Bleeding Webinar." Participants can earn continuing education and get a tool kit to use in talking with women about heavy bleeding.
Clinicians now have an approved indication in hand for use of the levonorgestrel intrauterine system Mirena (LNG IUS, Mirena, Bayer HealthCare Pharmaceuticals; Wayne, NJ), to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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