Intrauterine Contraceptive -- May 7, 2003

Research Triangle Park, NC -- New research confirms that the hormone-releasing intrauterine system Mirena, traditionally used for contraception, also dramatically reduces menstrual bleeding associated with uterine fibroids. The study of 67 women with these noncancerous tumors of the uterus showed a six-fold decrease in menstrual blood loss after just one year of Mirena use.

"Uterine fibroids are a huge public health problem for both developed and less-developed countries," says principal author Dr. Vera Grigorieva of Family Health International.

Quite common, fibroids are present in about a quarter of women ages 30 years and older. While most are asymptomatic, many others cause significant discomfort, pain, or menstrual blood loss, the latter of which can lead to medical problems such as iron-deficient anemia.

The traditional treatment for symptomatic fibroids is hysterectomy. But the procedure is invasive, can be expensive, and is not ideal for all women, especially those who want to maintain their fertility. In the United States, uterine fibroids account for nearly half of the 600,000 hysterectomies performed each year.

"The results of our study show that Mirena may be a medical, long-term alternative to surgery, since so far the choice of nonsurgical interventions for uterine fibroids has been quite limited, says Dr. Grigorieva.

Mirena is a T-shaped plastic contraceptive device that is inserted into a woman's uterus where it releases daily, low doses of a progestin called levonorgestrel. This hormone acts primarily by suppressing growth of the lining of the uterus. As a result, Mirena has several important noncontraceptive benefits, including reducing menstrual blood loss and possibly preventing the development of uterine fibroids. But the device had not been specifically tested for its effects in a large group of women with existing fibroids.

The study, published in the May 2003 issue of the journal Fertility and Sterility, included 67 women ages 20 to 45 years old who had at least one uterine fibroid and chose Mirena for contraception. Throughout the one-year study, researchers from Family Health International and the Ott Institute of Obstetrics and Gynecology in Russia monitored the women for menstrual blood loss, levels of hemoglobin and ferritin (two compounds in the blood that can be used to diagnose or predict iron deficiency), and uterine and fibroid size.

Of 26 women who were diagnosed with heavy menstrual bleeding before the study, only four still reported excessive bleeding at three months, and blood loss continued to decline until the end of the study. Hemoglobin and ferritin levels increased over the same period, indicating improved levels of iron in the blood. Of 19 women diagnosed with anemia before the study, only seven remained anemic at three months and only one was still anemic after one year. The researchers also confirmed earlier findings that Mirena can reduce uterine fibroid size, but size was reduced only slightly by six months.

In April, researchers from the University of Naples in Italy reported results of a study of 19 women who had heavy bleeding associated with uterine fibroids and were given Mirena as an alternative to hysterectomy. Mirena reduced menstrual blood loss and iron deficiency in these women as well, but the results were not as encouraging as those reported by Dr. Grigorieva and colleagues.

More studies still need to be done before the U.S. Food and Drug Administration (FDA) could be approached to seek approval to market Mirena as the first long-term nonsurgical treatment for heavy bleeding associated with uterine fibroids.

In 2000, the FDA approved Mirena for five years of use as a contraceptive. It is currently available in more than 50 countries and has been used by more than two million women worldwide. For more information on the device, see Network article.

Source

Grigorieva V, Chen-Mok M, Tarasova M, Mikhailov A . Use of a levonorgestrel-releasing intrauterine system to treat bleeding related to uterine leiomyomas. Fertil Steril 2003;79(5):1194-98.

Family Health International is dedicated to improving lives, knowledge, and understanding worldwide through a highly diversified program of research, education, and services in family health and HIV/AIDS prevention and care. Since our inception in 1971, FHI has formed partnerships with national governments and local communities in countries throughout the developing world to support lasting improvements in the health of individuals and the effectiveness of entire health systems.