Abstract
PurposeA multicenter, randomized, double‐blind, placebo‐controlled trial was conducted to evaluate the efficacy, safety, and appropriate dose of ulipristal acetate (UPA) in Japanese women with symptomatic uterine fibroids (UFs).MethodsA total of 121 premenopausal women with UFs were enrolled to receive either placebo, UPA‐2.5 mg, UPA‐5 mg, UPA‐10 mg, or leuprorelin acetate (LEU), a reference drug, for 12 weeks. The primary end point was the rate of patients having achieved amenorrhea for 35 days at Week 12.ResultsThe rates for amenorrhea were 4.5%, 60.0%, 72.7%, 88.0%, and 76.2% in the placebo, UPA‐2.5 mg, UPA‐5 mg, UPA‐10 mg, and LEU groups, respectively. The median times to amenorrhea were 20.0, 5.0, 5.0, and 23.0 days for treatment with UPA‐2.5 mg, UPA‐5 mg, UPA‐10 mg, and LEU, respectively. A significant dose‐response of UPA for the rate of amenorrhea was observed. The overall incidence rates of adverse events were 45.8% in the placebo group, 56.5%‐80.0% in the UPA groups, and 100.0% in the LEU group. There were no notable safety issues with UPA.ConclusionsUlipristal acetate was effective and well tolerated in Japanese women with UFs. The recommended dose of UPA is considered to be 10 mg.
Highlights
Uterine fibroids (UFs) are common benign uterine smooth muscle tumors with a prevalence range of 4.5%‐68.6% depending on race and age.[1]
The radical treatment for UFs is total hys‐ terectomy and conservative treatments such as myomectomy or pharmacotherapy are selected for patients who want to preserve the uterus or fertility.[6]
Eligible pa‐ tients were randomly assigned into five treatment groups—placebo, ulipristal acetate (UPA) 2.5 mg (UPA‐2.5), UPA 5 mg (UPA‐5), UPA 10 mg (UPA‐10), and leuprorelin acetate (LEU)—using an allocating factor of the presence or absence of iron therapy (Figure 1)
Summary
Uterine fibroids (UFs) are common benign uterine smooth muscle tumors with a prevalence range of 4.5%‐68.6% depending on race and age.[1]. (GnRH) agonists or antagonist are the only drugs approved for UFs in Japan and provide effective therapeutic options These drugs induce an artificial menopausal state that results in improving symptoms and reducing uterine and fibroid volume.[9,10] there are safety issues for both types of drugs concerning loss of bone mineral density due to low blood estrogen levels[10,11]; there‐ fore, the treatment duration is limited to up to 6 months in Japan. This is the first randomized, controlled study of UPA for UFs in an Asian population
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