The drug Progenta is now being used in a European study to test its effectiveness in treating uterine fibroids.The study, to be conducted in Warsaw, Poland, will include 30 women with uterine fibroids. The women will be selected from a pool of women referred by various gynecologists in Warsaw. This group is to be split at random into five sub-groups: a placebo group, a group that will receive a traditional approved gonadotropin releasing hormone agonist (GnRHa), and three more groups, each receiving a different amount of Progenta.
The study hopes to gauge the effectiveness of Progenta as an alternative to traditional GnRHa therapy. GnRHa use, while proven to slow, stop, and even reverse the growth of uterine fibroids as a conservative therapy or a pre-surgery therapy, have also been shown to lead to reduced bone mineral density, which itself can lead to osteoporosis, a condition in which bones are brittle, weak, and easily broken. Other side effects of GnRHa use include reduced hemoglobin (the oxygen carrying protein in red blood cells) menopause-like symptoms such as mood changes, irritability, depression, and hot flashes.
The research team conducting the Progenta study hopes to find it superior to GnRHa treatment both because of its ability to treat fibroids as well as, or better than GnRHa regimens and also because of a reduction in troubling, and potentially dangerous, side effects.
According to the Zonagen press release, up to 70 percent of women have uterine fibroids at some point in their lives, but because not all women know that they have fibroids, many go undiagnosed for years or may never know they have them. They occur primarily in women in their late reproductive years, usually those between about 35 and 45 years of age (once menopause occurs, the hormonal changes often cause existing fibroids to shrink or disappear).
Uterine fibroids are benign (noncancerous) tumors in the uterus or in the wall of the uterus. They can range in size from the size of a pea to the size of a grapefruit. Fibroid tumors can cause a number of troubling and painful symptoms, such as an enlarged abdomen that resembles pregnancy, digestive and urinary problems including urinary incontinence, abdominal pain, abnormally profuse or irregular bleeding (menorrhagia or metrorrhagia), pain during sexual intercourse (dyspareunia), and infertility or frequent miscarriage.
Drug therapy for fibroids represents a great step forward in women’s health care, because it will likely help to reduce the staggering number of hysterectomies performed annually (about 600,000 per year is the estimate for the United States alone).
Hysterectomy, in addition to carrying with it all the risks of a major surgery (anesthesia, long recovery time, and risk of infection or hemorrhage), also renders women permanently infertile, can compromise their sexual sensation, and may cause scar tissue to build up and crowd other abdominal structures, and doctors are increasingly eager to find ways to eliminate the need for such extensive and problematic surgery by combining the benefits of new, promising drug therapies and minimally invasive treatments.
