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. 2017 Apr 26;2017(4):CD010770. doi: 10.1002/14651858.CD010770.pub2

NCT02147158.

Trial name or title A Study of the Safety and Efficacy of Intermittent Ulipristal Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Methods Randomised controlled trial
Participants Cyclic abnormal uterine bleeding (heavy or prolonged)
 Menstrual blood loss (MBL) ≥ 80 mL in the first 8 days of menses
 Minimum of 1 discrete leiomyoma observable by transvaginal ultrasound
Interventions Various permutations of ulipristal acetate 5 mg or 10 mg or placebo
Outcomes Absence of bleeding (time frame: 12 weeks)
 Time to absence of bleeding (time frame: 12 weeks)
Starting date January 2014
Contact information Watson Pharmaceuticals
Notes