Long-term treatment of uterine fibroids with ulipristal acetate  

Oleh:

Donnez, Jacques ; Vazquez, Francisco ; Tomaszewski, Janusz ; Nouri, Kazem ; Bouchard, Philippe

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Fertility and Sterility (keterangan: ada di ClinicalKey) vol. 101 no. 06 (Jun. 2014), page 1565–1573.
Topik: Long-term treatment; ulipristal acetate; uterine fibroid

Ketersediaan

Perpustakaan FK Nomor Panggil: F02.K.2014.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

Lihat Detail Induk

Isi artikel

Objective To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids. Design Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo. Setting European clinical gynecology centers. Patient(s) Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding. Intervention(s) Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo. Main Outcome Measure(s) Amenorrhea, fibroid volume, endometrial histology. Result(s) After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2–6 days). Median fibroid volume change was -45% (interquartile range, -66%; -25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were -63%, -67%, and -72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology. Conclusion(s) Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids. Clinical trial registration ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).

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