Efficacy and Safety of Repeated Use of Ulipristal Acetate in Uterine Fibroids.

ABSTRACT

Uterine fibroids are benign tumor of the uterus that often appear during child bearing ages. Medical treatments are considered the first-line treatment to preserve fertility, avoid or delaying surgery. This randomized control study was carried out in OPD of Obstetrics and Gynecology Department of BSMMU, Dhaka, Bangladesh from May 2018 to March 2019 to evaluate the efficacy and safety of ulipristal acetate (5mg) once daily in reproductive women with three months treatment courses. Total 52 samples with symptomatic uterine fibroids for treatment course-1, among them 36 were needed for treatment course-2 which was slow or non-responding in treatment course-1. Main outcome measures were amenorrhea, controlled bleeding, fibroid volume, anaemia, quality of life. Sixty one percent (61.0%) of patients were achieved amenorrheic during both treatment courses. Ninety percent (90.0%) patients were control of bleeding during both treatment courses. In treatment course-1, reductions from baseline in fibroid volume were 62.70%, whereas in course-2, reductions in fibroid volume were 75.33%. Five percent (5.0%) of patients were discontinuing Ulipristal acetate due to adverse effects. Renal and liver function tests were performed before and after each course of treatment. The level of creatinine, SGPT in the blood for both treatment courses had no statistically significant effects. Ulipristal acetate may be an alternative to surgical treatment, the safety profiles and prolong effects with improvement of symptoms, quality of life after cessation of drugs. Repeated use of drugs reduces the size and also improves the patient's condition.