In a nutshell
The authors studied the effectiveness and safety of ulipristal acetate in managing fibroids in the long term.
Some background
Fibroids are benign tumors (non-cancerous growths) from the muscle cells of the uterus (the womb). It is associated with heavy menstrual bleeding, pain in the pelvic area and reproductive problems.
Surgery to remove the fibroid is the usual treatment. Drugs have also been developed to reduce symptoms of bleeding and the size of the fibroid. However, there is still a need for effective long-term medical therapy for patients who do not wish to have surgery. It has been suggested ulipristal acetate could potentially manage fibroids in the long term. Ulipristal acetate works to prevent the fibroid from growing.
Methods & findings
209 women with at least one fibroid and who were eligible for fibroid surgery were studied. Women received a 3 month course of ulipristal acetate once daily. Some women entered an extension study where they received additional courses of ulipristal acetate.
At the end of the first treatment course, 78.5% of women had amenorrhea (absent menstrual periods). The average time to amenorrhea was 3.5 days. 89% of women who received the second treatment course had amenorrhea. 88% of women who received the third treatment course and 90% of women who received the fourth treatment course had amenorrhea.
The average reduction in fibroid volume was 45.1% after the first 3-month course of ulipristal acetate. The average reduction in fibroid volume was 72.1% after four treatment courses. During the first treatment course, patient's pain levels improved from the 5th week onwards.
There were no serious adverse events (undesired effect of treatment) during the first course of ulipristal acetate. During this course, some women experienced headache, the common cold and abdominal pain. 8 women discontinued the study due to adverse events.
The bottom line
The authors concluded that repeated 3-month courses of ulipristal acetate is an effective and well-tolerated long-term medical treatment for fibroids.
Published By :
Fertility and Sterility
Date :
Mar 12, 2014