Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5？mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. “Eusebio Hernández” Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5？mg) or one-whole 5？mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20–35) and 45.5% (CI 95% 37–62), in the 2.5 and 5？mg groups, respectively, . There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5？mg group, . There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5？mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5？mg dose. This trial is registered with ClinicalTrials.gov NCT01786226. 1. Introduction The selective progesterone receptor modulators (SPRMs) are proving to be a new source of hope in treating uterine fibroids [1, 2]. Recently, ulipristal acetate has been authorized for use in the European Union in 5？mg daily doses over 3 months to improve symptoms in presurgery patients [3, 4]. The oldest, almost pure antiprogestin, mifepristone, has shown great effectiveness with different dosages in multiple studies into the treatment of this condition [5, 6]. Mifepristone in 5？mg doses has proven itself to be an efficient and safe therapeutic medicine as well as achieving an observable improvement in quality of life [5–10]. Eisinger et al. in a 17-case pilot study using 2.5？mg doses of mifepristone obtain lesser reductions in uterine volume, but a similar quality of life in comparison with 5？mg mifepristone [11]. Feng et al. demonstrate that the improvement in quality of life obtained with 2.5 or 5？mg doses of mifepristone is partially related to the reduction in symptoms, particularly pain and bleeding, but bears no relationship with reduction in uterine volume [9]. The aim of this study is to evaluate the effectiveness, safety, and quality of life obtained using 2.5 versus 5？mg mifepristone daily over 3-month treatment and 9-month followup. 2. Material and Methods 2.1. Design This randomized clinical
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