An observation study of the clinical evaluation of symptom relief and side effects associated with taking ulipristal acetate (esmya) including its effect on pre-menstrual syndrome.

This was an observational study investigating the efficacy and side effects associated with ulipristal acetate (UPA), a progesterone receptor modulator, and the possible benefits to women who have co-existing pre-menstrual syndrome (PMS). 80 women returned a questionnaire on the bleeding, menstrual pain and side effects, and changes on PMS were recorded. 67 women (84%) showed improvement in their menses. 54 women (67%) became amenorrhoeic. Of those, 67% were within 10 days of commencing UPA. Menses returned in 33 amenorrhoeic women within 4 weeks of stopping UPA. 58 women (70%) reported an improvement in their pain score but 41 women had a return of their pain after stopping UPA. The majority of the women had no or infrequent side effects. 80% had demonstrable improvement in their PMS symptoms. UPA is effective in controlling symptoms due to uterine fibroids with infrequent side effects. Our data also showed new evidence of a concurrent dramatic improvement in PMS in these women. Impact statement The observational study explored the drug profile of ulipristal acetate (UPA), a selective progesterone receptor modulator, which has been licenced as pre-treatment for surgical therapies of fibroids since 2012. We aimed to investigate the efficiency and side effects of UPA. Since the introduction of UPA in clinical practice, there has yet to be a study looking at the drug profile outside a research setting. We have also decided to investigate the effect of UPA on pre-menstrual syndrome (PMS) in this group of women with symptomatic fibroids. As such this case report should be of interest to a broad readership including those interested in the medical management of symptomatic fibroids.