Long-term treatment of uterine fibroids with ulipristal acetate^鈽?/sup>

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• 作者：Jacques Donnez ; M.D.^a ; ^{jacques.donnez@gmail.com" class="auth_mail} ; Francisco Vá ; zquez ; M.D.^b ; Janusz Tomaszewski ; M.D.^c ; Kazem Nouri ; M.D.^d ; Philippe Bouchard ; M.D.^e ; Bart C.J.M. Fauser ; M.D.^f ; David H. Barlow ; F.R.C.O.G.^g ; Santiago Palacios ; M.D.^h ; Olivier Donnez ; M.D.ⁱ ; Elke Bestel ; M.D.^j ; Ian Osterloh ; M.R.C.P.^k ; Ernest Loumaye ; M.D.^l ; for the PEARL III ; PEARL III Extension Study Group
• 关键词：Long-term treatment ; ulipristal acetate ; uterine fibroid
• 刊名：Fertility and Sterility
• 出版年：June 2014
• 年：2014
• 卷：101
• 期：6
• 页码：1565-1573.e18
• 全文大小：1680 K

文摘

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).