HealthDay News — For women with symptomatic uterine leiomyomas, ulipristal is well tolerated and superior to placebo for the rate of and time to amenorrhea, according to a study published online February 5 in Obstetrics & Gynecology.
James A. Simon, MD, from the George Washington University School of Medicine in Washington, D.C., and colleagues enrolled premenopausal women with abnormal uterine bleeding, 1 or more discrete leiomyomas, and uterine size 20 weeks gestation or less. One hundred fifty-seven patients were randomly allocated to receive 5mg ulipristal, 10mg ulipristal, or placebo (53, 48, and 56 patients, respectively) for 12 weeks followed by 12-week drug-free follow-up.
The researchers found that amenorrhea was achieved by 47.2, 58.3, and 1.8% of patients in the ulipristal 5mg and 10mg, and placebo groups, respectively. For both ulipristal doses, the time to amenorrhea was shorter than placebo; compared with placebo, both ulipristal doses resulted in improved quality of life. Hypertension, elevated blood creatinine phosphokinase, and hot flushes were common adverse events (5% of greater in either ulipristal group during treatment). Four patients experienced serious adverse events, but none was considered related to treatment.
“Ulipristal at 5mg and 10mg were well tolerated and superior to placebo in rate of and time to amenorrhea in women with symptomatic uterine leiomyomas,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Allergan, which funded the study.