Is ulipristal acetate safe and effective for the treatment of uterine fibroids?

This study examined whether ulipristal acetate is safe and effective for the treatment of uterine fibroids.

Uterine fibroids are benign (harmless) smooth muscle tumors (myomas) that occur in the uterus. They can result in heavy menstrual bleeding, infertility and a decrease in quality of life. Patients may also have low hemoglobin (protein in red blood cells which helps carry oxygen around the blood) levels (anemia).

Ulipristal acetate (Esmya) is a drug given orally which is may be used to treat uterine fibroids. Previous studies have shown that 10 mg of ulipristal acetate is effective for the treatment of uterine fibroids. However, it is not known whether repeated administration of 5 mg is safe and effective for the treatment of uterine fibroids. 

This study aimed to determine the safety and effectiveness of repeat ulipristal acetate for the treatment of uterine fibroids.

This study involved 451 women with uterine fibroids and heavy menstrual bleeding. Participants received four 12-week courses of ulipristal acetate. 228 participants received 5 mg of ulipristal acetate. 223 participants received 10 mg of ulipristal acetate.

Ulipristal acetate was effective in controlling bleeding symptoms. Approximately 70% of participants had amenorrhea (absence of menstruation) after treatment. This high rate was similar in both groups. Menstrual bleeding was lower after treatment with ulipristal acetate compared to before.

Hemoglobin levels increased after the first treatment and remained high with repeated treatment. Hemoglobin levels increased by an average of 0.55 g/dL in patients who received 5 mg ulipristal acetate. Hemoglobin levels increased by an average of 0.95 g/dL in patients who received 10 mg ulipristal acetate. The size of the myomas decreased with repeated treatment in 73.5% of patients. Pain also decreased with repeated treatment.

This study concluded that repeat administration of ulipristal acetate is safe and effective for the treatment of uterine fibroids.