Nearly 50% of women with symptomatic uterine fibroid achieved amenorrhea with Ulipristal Acetate as compared to placebo, reports the results of small randomized control trial published in March issue of Journal of Obstetrics and Gynecology.
Leiomyomas are the most common indication for hysterectomy in the United States affecting nearly 70% of white women and more than 80% of black women of reproductive age. About a quarter or 50% of women experience symptoms, the most common being heavy and irregular uterine bleeding.
Many medical treatment options like nonsteroidal anti-inflammatory drugs (NSAIDs), levonorgestrel intrauterine devices, and oral and nonoral combination contraceptives are prescribed in the treatment of symptomatic fibroids but data about their efficacy is limited.
Other off-label drugs that are used for short-term management include gonadotropin-releasing hormone agonists and tranexamic acid.
This multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group phase 3, (NCT02147197) was conducted at 25 study centers across the United States.
Premenopausal women between 18-50 years of age with one or more discrete leiomyomas and uterine size 20 weeks of gestation with menorrhagia were included in the study. The researchers looked at the rate of and time to amenorrhea (no bleeding for the last 35 consecutive days of treatment) as the co-primary endpoints and Uterine Fibroid Symptoms and Quality of life (QoL) as the secondary endpoints.
Over a period of 2 years, 157 patients with similar demographics were randomized 1:1:1 to once-daily oral 5 mg ulipristal, 10 mg ulipristal, or placebo followed by a 12-week drug-free period.
Patients fared significantly better with both the doses of ulipristal, in terms of achieving amenorrhea 25 of 53 (47.2%) and 28 of 48 (58.3%) patients treated with 5 mg and 10 mg ulipristal, respectively achieved amenorrhea as compared with 1 of 56 (1.8%) of placebo-treated patients (both P <.001).
Patients on ulipristal also reported an improved quality of life and a decrease in the amount of blood loss. At the end of follow-up period decrease in volume of the leiomyomas was also observed in ulipristal treated groups as compared to placebo where an increase was noted.
The small sample size and short duration of treatment were not enough to study the side effects but not a single patient discontinued the treatment because of side effects of the drug.
Other studies have shown that multiple 12-weeks courses of ulipristal (up to 8 coursed of 12 weeks duration each) is effective and well tolerated and maintains the efficacy and quality of life.
The authors concluded, “ulipristal may be useful for the medical management of abnormal uterine bleeding associated with uterine leiomyomas, especially for patients desiring uterine- and fertility-sparing treatment.”
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