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

Objectives: To evaluate the efficacy and safety of 5 and 10mg doses of mifepristone for 6 months for the treatment of uterine fibroids and to check those results at 1 year post-treatment.

Study Design: Randomised double-blind clinical study carried out at the "Eusebio Hernández" Hospital, Havana, Cuba. One hundred and seventy-six women with symptomatic uterine fibroids received one daily capsule of 10mg mifepristone orally or one daily capsule of 5mg mifepristone orally, over 6 months.