ArticleReproductive medicine and biology2020
Ulipristal acetate for Japanese women with symptomatic uterine fibroids: A double-blind, randomized, phase II dose-finding study.
Article in Reproductive medicine and biology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
5 citing papers in PubMed, 13 citations in OpenAlex.
- Effects of female hormone withdrawal and ulipristal acetate on MED12 mutation positive and negative uterine leiomyomas using a xenograft model.Scientific reports · 2025Article
- Hepatic Safety Considerations in the Use of Ulipristal Acetate for Symptomatic Uterine Fibroids.Therapeutics and clinical risk management · 2025Review
- Phase III long-term study to evaluate the efficacy and safety of ulipristal acetate in Japanese patients with uterine fibroids.The journal of obstetrics and gynaecology research · 2021Article
- Safety and efficacy of two repeated cycles of ulipristal acetate in the management of symptomatic uterine fibroid among Indian women.Przeglad menopauzalny = Menopause review · 2021Article
- Ulipristal acetate for Japanese women with symptomatic uterine fibroids: A double-blind, randomized, phase II dose-finding study.Reproductive medicine and biology · 2020Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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