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Ulipristal acetate use in adenomyosis: A randomized controlled trial
Perrine Capmas1, Jean-Luc Brun2, Guillaume Legendre3
1Gynecology Obstetric Department, Bicetre Hospital, GHU Sud, AP-HP, F-94276, Le Kremlin Bicetre, France; Inserm, Centre of Research in EPIDEMIOLOGY and Population Health (CESP), U1018, F-94276, Le Kremlin Bicetre, France; Medical School, University Paris Sud, F-94276, Le Kremlin Bicêtre, France.
Objective:
To evaluate the effect of a 10 mg per day 12 week treatment of ulipristal acetate (UPA) on abnormal uterine bleeding due to adenomyosis.
Design:
A double-blind phase 2 randomized controlled pilot study.
Setting:
From May 2015 to February 2018 in five teaching hospitals.
Population:
Premenopausal 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.
Methods:
After random allocation, either UPA 10 mg or placebo were orally administered during 12 weeks. A 3:1 ratio was used.
Main Outcome Measures:
The 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.
Results:
Thirty 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.
Conclusion:
UPA could be an interesting option for treatment of abnormal uterine bleeding related to adenomyosis in women wishing to preserve their fertility.
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