Safety and efficacy of two repeated cycles of ulipristal acetate in the management of symptomatic uterine fibroid among Indian women

INTRODUCTION: To evaluate the safety and efficacy along with the impact on uterine and fibroid vascular indices of 2 repeat 12-week courses of ulipristal acetate (UPA) among Indian women. MATERIAL AND METHODS: Ninety-four premenopausal women aged 18-45 years with at least 1 symptomatic fibroid of size ranging from 1 cm to 10 cm were included in the study. All participants received 2 courses of 5 mg of UPA orally for 12 weeks starting from the 5th day of their menstrual cycle with a 2-menstrual-cycle break in between. The efficacy was measured in terms of time to amenorrhoea, percentage of women who achieved amenorrhoea for the last 35 consecutive days, reduction in uterine and fibroid volume, as well as its vascularity at the end of the first and second treatment cycle. RESULTS: Eighty-six women completed the first treatment cycle whereas only 65 women completed the second treatment course. Seventy-nine per cent of women achieved amenorrhoea for 35 consecutive days during the first treatment cycle. Median time to amenorrhoea was 7 days and 5 days during the first and second treatment cycle, respectively. Percentage reduction of the mean fibroid volume was 32% and 52% after the first and second treatment cycle, respectively. We observed an increase in fibroid vascular indices (pulsatility index and resistive index) suggesting reduction in fibroid vascularity. Serum oestradiol remained at mid-follicular phase. No serious drug emergent side effect was noted. CONCLUSIONS: Two interrupted repeat course of 5mg UPA is well tolerated efficient and safe in symptomatic fibroid among Indian women.