Feb. 1, 2012 -- A new drug appears to be effective for shrinking uterine fibroids and controlling the heavy menstrual bleeding they often cause, according to new research from Europe.
In one study, the drug ulipristal acetate proved to be much more effective than a placebo for shrinking the non-malignant uterine tumors.
In another, ulipristal acetate was found to be as effective as monthly injections of the drug Lupron for reducing heavy bleeding in women with uterine fibroids.
Both studies appear in the Feb. 2 issue of The New England Journal of Medicine.
Ulipristal acetate is the active chemical in the emergency contraceptive sold in the U.S. as Ella, but the daily doses taken by the fibroid patients in the studies were much smaller than those in the contraceptive.
If trials now under way in the U.S. prove positive, New Jersey-based Watson Pharmaceuticals Inc. and Swiss-based PregLem hope to market ulipristal acetate as a fibroid treatment under the trade name Esmya, says Watson spokesman Charlie Mayr.
Uterine fibroids are the most common indication for the close to 600,000 hysterectomies performed each year in the U.S.
About 1 in 4 women in their childbearing years have symptoms related to fibroids, such as heavy periods and related iron deficiency, abdominal pain, and fertility problems, according to figures from the National Institutes of Health.
Surgery is the most common uterine fibroid treatment, but many women want a nonsurgical treatment option, says researcher Jacques Donnez, MD, PhD, of Saint-Luc Catholic University of Louvain in Brussels, Belgium.
Lupron improves symptoms and shrinks uterine fibroids, but it does not make them go away. It works by blocking the production of estrogen -- the hormone that fuels fibroids - and many women who take it develop hot flashes and other symptoms of menopause.
In one of the newly published studies, women with excessive bleeding caused by uterine fibroids who took ulipristal acetate for three months had similar improvements in bleeding as patients who got monthly injections of Lupron, with significantly fewer side effects.