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 |