ESMYA (ulipristal), progesterone receptor modulator

No clinical benefit demonstrated in sequential treatment of moderate to severe symptoms of uterine fibroids

• ESMYA has Marketing Authorisation in the sequential treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
• In a randomised, double-blind study comparing two dosages of ulipristal 5 mg/(MA dosage), with no reference group, the percentage of patients with amenorrhea was 61.9% at the end of the first two 12-week treatment cycles and 48.7% at the end of four 12-week treatment cycles
• An annual ultrasound should be performed in repeated sequential treatments and an endometrium biopsy should be done in cases of persistent thickening or change in the bleeding profile  in order to exclude other underlying conditions.