Long-term treatment of uterine fibroids with ulipristal acetate ☆

PEARL III and PEARL III Extension Study Group, Jacques Donnez, Francisco Vázquez, Janusz Tomaszewski, Kazem Nouri, Philippe Bouchard, Bart C J M Fauser, David H Barlow, Santiago Palacios, Olivier Donnez, Elke Bestel, Ian Osterloh, Ernest Loumaye, Alistair Williams (Member of Consortium)

Research output: Contribution to journalArticlepeer-review

Abstract

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).

Original languageEnglish
Pages (from-to)1565-73.e1-18
JournalFertility and Sterility
Volume101
Issue number6
DOIs
Publication statusPublished - Jun 2014

Keywords

  • Administration, Oral
  • Adult
  • Amenorrhea
  • Antineoplastic Agents, Hormonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Double-Blind Method
  • Drug Administration Schedule
  • Endometrium
  • Europe
  • Female
  • Humans
  • Leiomyoma
  • Menorrhagia
  • Middle Aged
  • Norethindrone
  • Norpregnadienes
  • Pelvic Pain
  • Quality of Life
  • Time Factors
  • Treatment Outcome
  • Tumor Burden
  • Uterine Neoplasms

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