Ulipristal acetate use in adenomyosis: A randomized controlled trial

Abstract

ObjectiveTo evaluate the effect of a 10 mg per day 12 week treatment of ulipristal acetate (UPA) on abnormal uterine bleeding due to adenomyosis. DesignA double-blind phase 2 randomized controlled pilot study.Setting: From May 2015 to February 2018 in five teaching hospitals. PopulationPremenopausal women with abnormal uterine bleeding (with a pictorial blood loss assessment score (PBAC) higher than 100 at inclusion) and a sonographic or MRI diagnosis of adenomyosis. MethodsAfter random allocation, either UPA 10 mg or placebo were orally administered during 12 weeks. A 3:1 ratio was used. Main outcome measuresThe primary outcome was the rate of women with a PBAC score of less than 75 as evaluated over the 28 days following the 12-week treatment. Secondary outcomes included rate of amenorrhea, evolution of pain, quality of life and tolerance. ResultsThirty women were included in the UPA group and 10 in the placebo group. No woman in the placebo group versus 95.24 % of women in the UPA group had a PBAC score under 75 during the 28 day period following the 12-week treatment (p < 0.01). A significant decrease in pain was noticed between inclusion and 13 weeks in the UPA group (p < 0.01). At 6 months, there was no significant difference in PBAC score or pain between groups. No serious adverse event was recorded. ConclusionUPA could be an interesting option for treatment of abnormal uterine bleeding related to adenomyosis in women wishing to preserve their fertility.