Mifepristone 2.5, 5, 10 mg versus placebo in the treatment of endometriosis

Objectives

To evaluate the effectiveness and safety of 2.5, 5 and 10 mg doses of mifepristone against a placebo in women with laparoscopic diagnostic of endometriosis.

Methods

Double-blind, placebo-controlled study of 360 subjects randomly assigned to receive orally one daily tablet of 2.5, 5 or 10 mg mifepristone for 6 month, or 1 daily tablet of mifepristone placebo for 3 months, (90 in each treatment group), carried out at “Eusebio Hernández” Hospital, Havana, Cuba. Efficacy was assessed by measuring changes in prevalence of dysmenorrhea and changes in scores according to AFS. Safety was evaluated by the incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.

Results

In the mifepristone groups, the prevalence of symptoms was significantly inferior to those at the beginning of treatment with no significant differences between the groups of 5 and 10 mg, unlike in 2.5 mg of mifepristone and the placebo group. The scores of the AFS were significantly different at the end of the treatment in the mifepristone groups. In the mifepristone groups, there were 9/264 (3.4%) subjects with raised hepatic transaminases up to 99 IU.

Conclusions

Mifepristone 5 mg was safer and more effective than the other mifepristone doses and placebo.

ClinicalTrials.gov Identifier: NCT02271958.