Evolución del leiomioma uterino después del tratamiento con mifepristona. Ensayo clínico aleatorizado

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, P = 0.003. 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, P = 0.001. 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.

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Effectiveness and Safety of Mifepristone in Different Dose (10 Mg and 25 Mg) for the Treatment of Uterine Fibroids and to Evaluate Quality of Life

Gupta¹

2016

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Evolución del leiomioma uterino después del tratamiento con mifepristona. Ensayo clínico aleatorizado

Cited by 3 publications

References 9 publications

Treatment of uterine myoma with 5 or 10mg mifepristone daily during 6 months, post-treatment evolution over 12 months: double-blind randomised clinical trial

Treatment of uterine myoma with 5 or 10mg mifepristone daily during 6 months, post-treatment evolution over 12 months: double-blind randomised clinical trial

Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

Effectiveness and Safety of Mifepristone in Different Dose (10 Mg and 25 Mg) for the Treatment of Uterine Fibroids and to Evaluate Quality of Life

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